standard of practice in clinical trials for pharmacy services...draft prepared 3.06.2019. property...

DRAFT prepared 3.06.2019. Property of The Society of Hospital Pharmacists Australia 1

Standard of practice in clinical trials for pharmacy services 1

Peter Slobodian, BPharm, MClinPharm, MSHP 1, June Challen, B. Pharm, MSHP 2, Michael Ching, post 2

nominals MSHP 3, Eugenia Hong, post nominals MSHP 4, Jasminka Nikolajevic-Sarunac, BPharm 3

MsMedSc Pharmacoepidemiology MFIP MEAHP MSHP 5, Brenda Shum, post nominals MSHP 6, Claire 4

Vosk, B.Pharm, BSc, MSHP 7, and Courtney Munro, BPharm, GradCertPharmPrac, MPharmPrac, 5

MSHP, AACPA 8 6

7

1 Royal Adelaide Hospital Pharmacy, Central Adelaide Local Health Network, SA Pharmacy, Adelaide, 8

Australia 9

2 The Queen Elizabeth Hospital, Central Adelaide Local Health Network, Woodville, Australia 10

3 Austin Health, Heidelberg, Victoria, Australia 11

4 Melbourne Health, Parkville, Victoria, Australia 12

5 John Hunter Hospital, New Lambton Heights, New South Wales, Australia 13

6 Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia 14

7 Monash Health, Clayton, Victoria, Australia 15

8 The Society of Hospital Pharmacists of Australia, Collingwood, Victoria, Australia 16

17

Address for correspondence: 18

Peter Slobodian1, Chair, Clinical Trials Leadership Committee, The Society of Hospital Pharmacists of 19

Australia, Collingwood, Victoria, Australia. Email: [email protected] 20

21

Preface 22

This Standard references and relies upon SHPA Standards of Practice for Clinical Pharmacy Services 1 23

as the foremost Standard. This Standard supersedes the previous SHPA Standards of Practice for 24

Pharmacy Investigational Drugs Services 2. 25

This Standard may overlap with others and depending on the area of specialty practice it may be 26

advisable to refer to additional Standards of Practice. 27

The use of the word ‘specialisation’ in this standard is in line with the National Competency 28

Standards Framework for Pharmacists in Australia 3 where ‘specialisation’ refers to the scope of 29

practice rather than the level of performance. ‘Specialisation’ of itself does not confer additional 30

expertise. 31

This Standard is for professional practice and is not prepared or endorsed by Standards Australia. It 32

is not legally binding. 33

34

mailto:[email protected]


Introduction 35

In Australia, everyone shares a fundamental right to safe and high-quality healthcare. This is 36

enshrined in the Australian Charter of Healthcare Rights 4 by which all healthcare systems, including 37

the provision of advanced pharmacy care, must abide. The Charter summarises the basic rights of 38

patients and consumers when accessing healthcare services including access, safety, respect, 39

communication, participation, privacy and comment. The provision of pharmacy services must 40

encompass the Charter to deliver effective, efficient, timely, and equitable patient-centred care. 41

The National Competency Standards Framework for Pharmacists in Australia 3 complements the 42

underpinnings of the Charter across five domains of competency for the pharmacy profession. These 43

include professionalism and ethics, communication and collaboration, medicines management and 44

patient care, leadership and management, as well as education and research. 45

This Standard, produced by The Society of Hospital Pharmacists of Australia (SHPA), refers to both 46

the role of the pharmacy service and the pharmacists’ practice in clinical trials. It is intended for both 47

pharmacists involved in clinical trial services and pharmacists whose area of specialisation is clinical 48

trial services and for consistency refers to both as clinical trials pharmacists. The Standard 49

predominantly refers to clinical trials pharmacists but does not intend to exclude suitably qualified 50

pharmacy technicians where appropriate 1. SHPA supports both pharmacists and pharmacy 51

technicians to operate at their full scope of practice in order to achieve optimal patient and 52

pharmacy outcomes 53

The Standard has been developed for pharmacists and pharmacy technicians involved with clinical 54

trials in their institutions. It relates to the management of investigational products used in clinical 55

trials and the facilities required for a clinical trials pharmacy services to align with the principles of 56

Good Clinical Practice (GCP) which have their origin in the World Medical Association’s Declaration 57

of Helsinki 5,6. Hospitals and other healthcare agencies are the major centres for clinical trials with 58

investigational products and pharmacists in these institutions should be involved with policies and 59

procedures for the safe and ethical use of investigational products. Implementation of these 60

guidelines should ensure the provision of a clinical trials pharmacy service acceptable to the 61

international community. 62

This Standard is intended to be used across hospital pharmacy services in Australia, irrespective of 63

the service type (public or private) or location (metropolitan, regional or rural). While this Standard 64

is intended for hospital pharmacy services, the principles and aspects of patient management 65

discussed herein can be applied to broader pharmacy services that provide clinical trials services. It is 66

acknowledged there are significant variations in pharmacy services that are dependent on 67

organisational capacity, patient population, clinical trials service and pharmacy department 68

priorities, and availability of clinical trials pharmacists; all of which may influence the scope of 69

services. 70

The Standard describes current best care for the provision of clinical trials pharmacy services by 71

clinical trials pharmacists, technicians and the pharmacy department or employer. 72

73

Objectives of the Service 74

The objectives of the clinical trials service provided by pharmacists are to: 75


• provide safe and ethical use of investigational products by ensuring that they are 76 appropriate for use and are procured, handled, stored and used safely and correctly 77

• apply the principles of best pharmacy practice to the evaluation of new medicines 78

• ensure pharmacy aspects of investigational drug use comply with relevant legislative Acts, 79 standards and guidelines 80

• consider the safety and welfare of clinical trial participants and protection of their rights, 81 confidentiality and privacy. 82

Clinical trials pharmacists must deliver the service as part of multidisciplinary collaboration and 83

within the framework of evidence and patient-centred healthcare ensuring optimal patient care. 84

85

Scope 86

This Standard applies to all pharmacists working in clinical trials services. The service provided by the 87

clinical trials pharmacist may be delivered across several settings including both public and private 88

hospitals, in an inpatient, outpatient or ambulatory care setting, and in community or domiciliary 89

settings. 90

In addition to providing Clinical Pharmacy services as outlined in SHPA Standards of Practice for 91

Clinical Pharmacy Services 1, clinical trials pharmacists are expected to provide services relevant to 92

their clinical area and scope of practice. The scope of services provided by clinical trials pharmacists 93

will be dependent on a variety of factors including: 94

• the setting, 95

• the patient population, 96

• the services the hospital or health service provides, 97

• funding models, 98

• governance structures for clinical trials services, 99

• clinical trials service and pharmacy department priorities, 100

• organisational priorities, and 101

• the scope of practice of the individual pharmacist. 102

Whilst the range of services provided in clinical trials is primarily delivered by pharmacists, it is 103

increasingly supported by pharmacy technicians in clinical and non-clinical roles. 104

The role of the clinical trials pharmacist should include: 105

• delivery of pharmacy services that improve patient medication outcomes and adds value to 106

healthcare systems, while encouraging the financial sustainability of healthcare 107

• development of and input into policies, procedures, guidelines and resources 108

• comment on clinical trials protocols 109

• provision of education and training for healthcare professionals and students 110

• quality improvement activities; and 111

• pharmacy research related to clinical trials 112

It may additionally include involvement in compounding or manufacturing investigational products, 113

services. The pharmacist should be a point of contact for other pharmacists and health professionals, 114

and for the hospital or health service for medicines enquiries related to clinical trials. 115

116


Users of the service include clinical trial participants and their carers, investigators and other health 117

professionals. 118

Coordination of the clinical trials pharmacy should be the responsibility of clinical trials pharmacist(s) 119

within the pharmacy service to ensure the maintenance of practice standards and consistency of 120

service provision and to ensure clinical trials involving investigational medicines are conducted 121

according to the principles of GCP. 122

Clinical trials pharmacists should develop services specific to their departmental and institutional 123

needs, but minimum services should include: 124

• stock management, storage, preparation and dispensing of all investigational products 125

• emergency 24-hour access to the service 126

• procedures to ensure compliance with clinical trial protocols 127

• counselling/educating clinical trial participants and monitoring compliance 128

• liaison with clinical trial investigator(s), trial coordinators and trial monitors 129

• providing information to participants and their carers, medical and nursing staff, other 130 pharmacists 131

• pharmacy involvement in the institutional review of protocols (via membership of a scientific 132 review committee and/or Human Research Ethics Committee (HREC). 133 134

In addition, clinical trials pharmacists may be involved in: 135

• clinical trial design 136

• protocol development 137

• randomisation codes (e.g. for blinded clinical trials) 138

• preparation of placebos and special dosage forms 139

• adverse drug reaction reporting 140

• literature searches 141

• therapeutic drug level monitoring 142

• advising on regulatory aspects of conducting clinical trials 143

• collection and analysis of data 144

• education of pharmacists, pharmacy students and other healthcare professionals 145

• importation of investigational medicine material 146

• distribution of investigational medicines to other study sites. 147 148

Operation 149

150

Policies, Procedures and Governance 151

Pharmacists must have knowledge of the following documents which provide a framework within 152

which they must practice: 153

• Australian Charter of Healthcare Rights 4 154

• National Safety and Quality Health Service Standards 7 including the National Model Clinical 155

Governance Framework 8 156

• Pharmacy Board of Australia Code of Conduct 9 157

• SHPA Code of Ethics 10 158

• National Competency Standards Framework for Pharmacists in Australia 3 159

• Professional Practice Standards 11 160


• Clinical Governance Principles for Pharmacy Services 12 161

• Relevant legislation Commonwealth, State and Territory Acts and Regulations including 162

Privacy Act 1988 13. 163

All aspects of the clinical trials pharmacy service should be conducted according to the following 164

standards and guidelines: 165

• Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) - 166 Annotated with TGA comments 5 167

• Access to Unapproved Therapeutic Goods - Clinical Trials in Australia 14 168

• Australian Clinical Trial Handbook: Guidance on conducting clinical trials in Australia using 169 ‘unapproved’ therapeutic goods 15 170

• NHMRC National Statement on Ethical Conduct in Human Research 16 171

• NHMRC Australian Code for the Responsible Conduct of Research 17 172

• Code of Good Manufacturing Practice (GMP) 18 173

• Commonwealth and state and territory privacy principles and legislation 19. 174 175

Investigational products in clinical trials should be subject to the same standards of dispensing, 176

labelling, stock management, participant counselling/education and drug information as those 177

required for TGA-registered medicines, with additional requirements as outlined in this Standard. 178

Trial Protocol Development and Review 179

Pharmacists should be involved in the review of protocols either by the membership of an HREC or 180

of a scientific review committee. If there is no clinical trials pharmacy membership of such 181

committees, there should be an opportunity for prior review by clinical trials pharmacists of the 182

clinical trial protocol, to assess the impact on the clinical trials pharmacy and other pharmacy 183

services. There must be a Research Governance (RGO) Site Specific Assessment (SSA) prior to any 184

study being conducted, which is signed by Head of, or Director of Pharmacy for any trial requiring 185

pharmacy input. 186

Experienced clinical trials pharmacists may be involved in developing or advising on the design of 187

new clinical trials particularly those generated within the institution or without external sponsorship. 188

Other pharmacists with specialist knowledge should be involved as appropriate. 189

Distribution and Control of Investigational Medicines 190

The Note for Guidance on Good Clinical Practice recommends that an investigator should delegate 191

responsibility for investigational drug(s) storage and accountability to an appropriate pharmacist5. 192

The clinical trials pharmacist/s must sign the trial delegation log and training log held in the 193

Investigator Site File (ISF) upon activation of the clinical trial. 194

The clinical trials pharmacy should develop and maintain written, and up to date standard operating 195

procedures (SOPs), including version control, for the handling of medicines used in clinical trials. 196

Drug Accountability Records 197

Drug accountability records should be maintained by the clinical trial pharmacist to identify at all 198

times the location and fate of all investigational product stock received by the site and details of all 199

transactions. 200

Drug accountability records should include the full details of the following: 201

• Investigational product receipt and confirmation at the trial site 202

• dispensing to individual clinical trial participants 203


• stock disbursement to usage areas 204

• participant returns 205

• transfers to other institutions 206

• returns to sponsor 207

• authorised destruction by the sponsor 208

• stock loss due to breakage, inappropriate storage conditions or unsuitability for use 209

• errors and corrective action that is taken. 210 211

Forms provided by the sponsor or purpose-designed forms may be used. Such forms should have 212

the identity of the clinical trial protocol, clinical trial site, principal investigator’s name and provision 213

for the recording of all the above information. 214

Black ball-point pens should preferably be used for drug accountability records. 215

Any corrections to drug accountability records should be crossed out with a single line, clearly signed 216

and dated, and an explanation/comment (if necessary), with the original entry still legible. “White-217

out” or blacking out on any documentation is not permitted. 218

Electronic accountability records may also be used and must be enabled to track all entries including 219

changes by date and electronic login or signature. 220

IVRS/IWRS/IxRS 221

Interactive voice response system (IVRS)/Interactive web response system (IWRS) or Interactive 222

voice/web response systema (IxRS) are electronic systems using voice-telephone or web-based 223

platforms for stock control is routinely used for clinical trials. IxRS should have personalised logins 224

which are password protected to allow for the identification of the person recording the entry. 225

Ordering and Receipt of Investigational Product 226

Methods of ordering vary with individual protocols. The clinical trials pharmacist should refer to the 227

specific protocol for drug ordering requirements and procedures. 228

Investigational products should be sent by the sponsor directly to the pharmacy and addressed to 229

the clinical trials pharmacist. 230

The clinical trials pharmacist should physically examine receipts to ensure all investigational 231

products are present, intact, correctly labelled as per shipment documentation and transported in 232

appropriate conditions. It is advisable to count every individual vial or bottle in multi-pack cartons 233

rather than rely on an outer carton label for contents. The following should be checked and recorded 234

in the drug accountability records: 235

• name or identification number of the investigational products 236

• name, strength and dosage form of the investigational products 237

• date of receipt 238

• quantity received 239

• expiry/retest date(s) 240

• batch/lot/serial number(s) 241

• unique code numbers assigned to the investigational product (if appropriate) 242

• numbers and quantity of any randomisation codes or envelopes received. 243 244

Any discrepancy should be reported to the sponsor directly and stock quarantined until the 245

discrepancy is resolved. 246


Once shipment documentation has been checked and found correct or amended/annotated as 247

required it should be signed and acknowledged as received by faxing or emailing and/or by 248

IVRS/IWRS as required by the sponsor. 249

All shipment documentation should be retained in the pharmacy clinical trial file. 250

Clinical trials pharmacists are sometimes involved in the importation of unregistered drugs. If the 251

unregistered medicine is not available from an Australian sponsor, an overseas source should be 252

found. When importing the unregistered medicines from the overseas supplier, it is important to 253

obtain appropriate types of licences and permits required prior to placing an order: 254

• import licence and permit issued by the Office of Chemical Safety are required to import 255 narcotic, psychotropic and precursor substances subject to Regulation 5 of the Customs 256 Regulations 1956 257

• import permit issued by the Office of Chemical Safety is required to import antibiotic and 258 anabolic/androgenic substances, subject to Regulations 5A and 5H respectively 259

• import permit issued by the Australian Quarantine and Inspection Service is required to 260 import biological products used for therapeutic or diagnostic use and containing and derived 261 from microorganisms, animal, human, plant or viral material. 262

263

Manufacture of Investigational Products 264

To ensure high standards of quality assurance for manufactured products, the general standards for 265

the manufacture of therapeutic goods as specified in the SHPA Guidelines for Medicines prepared in 266

Australian Hospital Pharmacy 20 should be followed. The Australian Code of Good Manufacturing 267

Practice for Medicinal Goods-Investigational Medicinal Products 18 particularly Annex 13 - 268

Manufacture of Investigational Medicinal Products should also be considered. Guidelines for 269

handling cytotoxic medicines and/or targeted therapies should be adhered to when appropriate 21-23. 270

It is important that information on the safe handling of investigational medicines is available to all 271

pharmacy and other staff who may be involved. Occupational health and safety issues are 272

paramount in the handling of products in the early stages of development. 273

Storage of Investigational Products 274

Investigational products should be stored separately from the normal pharmacy in an area with 275

access restricted to pharmacy staff, and where possible, access only to clinical trial pharmacists. 276

Investigational products should be stored at the required temperature and environmental 277

conditions, e.g. humidity as specified in the protocol, investigator’s brochure or approved product 278

information and according to the appropriate statutory regulations for registered medicines and in 279

accordance with special requirements e.g. cytotoxic medicines 20. Refrigerators and freezers used to 280

store investigational products should meet the Australian standards for medical or vaccine 281

refrigerators/freezers. All refrigerators, freezers and cold rooms must be connected to essential 282

power. 283

There should be monitoring and documentation of storage conditions. All refrigerators, freezers, 284

cold rooms and ambient storage areas should be linked to the hospital Building Management System 285

(BMS) and/or a stand-alone validated Environmental Monitoring System (EMS). Alternatively, 286

commercial individual temperature recorders with a back-up alarm system are recommended. 287

Temperature monitors should be serviced and re-calibrated annually and documentation of this 288

kept. Temperature logs should be maintained either in paper form or electronically and made 289

available to monitors, auditors or investigators on request. 290


In the event of a temperature alarm and/or excursion the following actions should be taken: 291

• check the temperature readings for deviations 292

• quarantine the investigational product and transfer stock to the back-up facility as per the 293 Business Continuity Plan 294

• note the time of transfer and/or transfer a portable temperature data logger with the 295 products 296

• notify the sponsors as soon as practicable (including a copy of the temperature readings) 297

• do not dispense quarantined investigational medicines until authorised by the sponsors 298

• contact the appropriate technician to investigate the alarm incident and/or to repair 299 equipment. Obtain and file the technician’s report which may include preventative measures 300 for future incidents 301

• write a file note/report of the alarm incident and file it with the relevant temperature 302 records. 303

304

Quarantined investigational products should be clearly identified and segregated from working 305

medicines. 306

Investigational products should be separated and labelled on a per protocol basis. Investigational 307

products should preferably be stored in the pharmacy until needed. If the investigational products 308

are stored outside the pharmacy as agreed upon by the service e.g. to permit emergency access, 309

they should be regularly audited to ensure appropriate storage, drug accountability recording and 310

security of the medicine. 311

Expiry date monitoring 312

Investigational products under development have limited stability data. The stock may have re-test 313

dates instead of the expiry date. Re-test dates need to be regularly updated and stock relabelled as 314

new storage stability data becomes available. A system for monitoring short-dated stock needs to be 315

implemented. 316

Dispensing of Investigational Products 317

Specific dispensing instructions should be developed for each protocol (according to the Clinical 318

Trials Pharmacy SOPs. The specific dispensing requirements for each visit should be detailed. 319

Requirements during dispensing include the following: 320

• verification that the clinical trial protocol has HREC approval (prior to first clinical trial 321 dispensing) 322

• verification that the prescriber is an authorised investigator (i.e. listed on the HREC 323 application/approval) 324

• verification that the patient (for whom the prescription is written) is registered on the 325 clinical trial 326

• concordance of dosage and regimen with the protocol 327

• confirmation that the participant meets the requirements for treatment (if appropriate) 328

• compounding of sterile preparations (if required) as per the specific clinical trial 329 requirements 330

• concordance of concomitant and disallowed therapy with the protocol 331

• verification of correct randomisation (if required) 332

• verification of IWRS allocation 333

• requirement for a second check of all randomised prescriptions 334

• completion of accountability record/s 335


• labelling with a standard pharmacy dispensing label such that the clinical trial, investigator 336 and institution can be identified at all times and in accordance with the protocol. Sponsor 337 required information should not be obscured 338

• retention of additional documentation such as original prescriptions and computer records 339 in a readily accessible manner to allow verification of the dispensing records. 340

341

Investigational product accountability record(s) should be completed at the time of dispensing by 342

the dispensing pharmacist. The following information should be included in the accountability form: 343

• identification of the clinical trial by protocol number 344

• clinical trial site 345

• name of the principal investigator 346

• name, strength and dosage form of the investigational product 347

• participant initials 348

• participant clinical trial assigned identification (ID) number 349

• date of dispensing 350

• dosage and quantity dispensed 351

• batch and re-test (expiry) date of investigational product 352

• dispensing pharmacist’s signature. 353 354 Accountability records for investigational products may also include: 355

• balance of investigational product at a site 356

• date and quantity of returned investigational product 357

• kit numbers and/or stickers for patient-specific investigational product 358

• date of the destruction of investigational product 359

• protocol specific information e.g. weight/BSA of the participant, the volume of medicine. 360 361

A clinical trial participant master list with full name and hospital record number (for pharmacy use), 362

clinical trial ID number and randomisation arm/dose level (if appropriate) should be maintained. 363

While the dispensing record may include specific participant details such as name and address, any 364

records forwarded to the sponsor must not contain participant identifying information, other than 365

initials and/or clinical trial assigned ID number. 366

Electronic accountability records may also be maintained by the pharmacy. The electronic system 367

must have a personalised login system which identifies the pharmacist recording entries and contain 368

security to prevent unauthorized access. If original data is modified the system should maintain a 369

viewable audit trail that shows the original data as well as the reason for the change, name of the 370

person making the change and date of the change. An adequate backup system must be employed 371

to prevent loss of data. Originals or validated copies of all prescriptions or clinical trial drug orders 372

should be kept to validate accountability records. 373

Return of Investigational Products by Participants 374

Clinical trial participants should return any unused investigational products or empty containers to 375

the pharmacy. Date and quantity of participant returns (or the number of empty containers) and 376

signature of person recording participant returns should be documented in the drug accountability 377

records. Returned medicines should be stored such that it is clearly distinguishable from 378

undispensed stock until confirmation by a trial monitor and returned to the sponsor or destroyed. 379

Any participant names or identifiers (other than initials and/or clinical trial ID numbers) on the 380


containers should be removed or blacked out before returning to the sponsor to maintain patient 381

confidentiality. Reissue of returns with specific handling requirements should be discouraged. 382

Any potentially dangerous or contaminated products returned by participants, such as needles, 383

syringes, broken ampoules, should be in appropriate sealed containers provided by sponsors. It is 384

recommended that these be destroyed as soon as possible after receipt by the usual pharmacy 385

procedures. Gloves should be worn and counting devices cleaned after each use for returned oral 386

cytotoxic and other hazardous medicines as per relevant local guidelines 21,22,25 387

Transfer/Distribution to other Institutions 388

Investigational products should only be transferred to another site with the permission of the 389

investigator and the sponsor. All transfers should be recorded on drug accountability records and 390

receipt should be acknowledged. Investigational products should be transferred under the required 391

temperature storage conditions as specified in the protocol. Records of temperature during transit 392

and upon receipt need to be kept and filed. Transfer of cytotoxic medicines or genetically modified 393

products requires additional precautions 22. 394

An authorised recipient in the receiving institution should be responsible for the receipt of 395

investigational products. The authorised recipient should be provided with pertinent information 396

including participant details (if applicable), clinical trial protocol or relevant drug information, local 397

investigator, storage and handling instructions, drug accountability details and forms, contact names 398

and telephone numbers. Transfer records should be kept at both sites. 399

Pharmacy departments may be asked to act as a distribution centre for investigational products to 400

other sites. This is not considered a standard service. If undertaken, detailed SOPs should be 401

developed for each individual study. 402

Return and Disposal of Investigational Products 403

Investigational products may be returned to the sponsor due to the following reasons: 404

• the trial is completed or closed 405

• a participant has returned unused an investigational product to the pharmacy 406

• the investigational product has expired and re-test (expiry) date will not be extended 407

• the investigational product has been stored improperly 408

• the stock is damaged 409

• the sponsor has requested the return of the medicine. 410 411 Alternatively, the sponsor may authorise the destruction at the clinical trial site. This is usually done 412

by incineration at high temperature or by appropriate destruction methods, in accordance with SOPs 413

of the clinical trials pharmacy. The SOPs need to include specific details of the sites destruction 414

procedure. 415

All returns or investigational products approved destruction, should be recorded in the drug 416

accountability records, with details including batch/kit numbers and quantity recorded, date of 417

destruction. Destruction logs documenting full details of name, strength, quantity, batch number, 418

expiry (re-test) date, and date of destruction should be completed and kept in the pharmacy file. In 419

addition, records of randomisation codes returned to the sponsor or destroyed should be recorded 420

with other clinical trial records. 421


Retention and Archiving of Records 422

All records relating to the clinical trial should be retained following trial closure for a minimum of 15 423

years for adult participants and 25 years for paediatric participants in a secure accessible place, or 424

for longer if required by the sponsor 5. The clinical trials pharmacy service should have a 425

documented procedure for archiving pharmacy records. The system used for archiving must allow 426

for retrieval in a timely manner of any pharmacy study file or non-study specific documentation, 427

such as temperature monitoring records, training records of pharmacy staff, etc. Increasingly, 428

archiving of records may be off-site and pharmacy may choose to be responsible for original 429

prescriptions and invoicing and return other documentation to the site for archiving. Some states 430

and territories may have existing guidance regarding retention and archiving and should refer to 431

such. 432

Documentation 433

Standard Operating Procedures (SOPs) 434

The clinical trials pharmacy should develop written SOP for all their standard services such as clinical 435

trial set up, receipt of the drug, temperature monitoring, archiving etc. 436

File Notes 437

Any event occurring during the administration of a clinical trial which is unexpected, unusual or falls 438

outside the requirements of the protocol, e.g. dispensing error, temperature excursion should be 439

documented in a file note. This is important in explaining anomalies for monitoring and auditing 440

purposes. 441

Training 442

Documentation of training should be kept for each protocol with a record of pharmacists and 443

technicians trained. Protocol and investigator brochure (IB) amendments involving changes in 444

pharmacy procedures require all pharmacists and technicians working with the trial to be retrained 445

and a record of this training must be kept. 446

Clinical Trial Participant Care 447

Clinical Trial Participant Education 448

The clinical trials pharmacist needs to work closely with study staff involved with the participant’s 449

treatment to ensure that education regarding investigational products is adequate and appropriate. 450

The participant will have been given written information by the investigator during the informed 451

consent process. However, supplementary education by the clinical trials pharmacist is considered 452

best practice to ensure protocol compliance and safe and appropriate use of investigational 453

products. 454

Preparation of an information leaflet may be used to assist this process, and education should 455

reinforce written information as per usual professional responsibility. Information leaflets provided 456

to participants will require HREC approval and sponsor approval. Education should be based on the 457

SHPA Standards of Practice for Clinical Pharmacy 1. 458

Monitoring Compliance 459

Clinical trial participant compliance and its monitoring are important in clinical trials and clinical 460

trials pharmacists should: 461

• Promote participant compliance by ensuring they understand the education given and the 462 importance of investigational product compliance 463


• Check at regular intervals appropriate to the clinical trial (as per protocol/sponsor requirements) 464 that each participant is following instructions about the correct use of the investigational 465 product 466

• Counsel patients to return all investigational products at each visit 467

• Ensure that records are kept for returns of used and unused supplies and/or packaging, as 468 required by the sponsor 469

• Notify the study staff if a participant has not adhered with protocol or sponsor requirements 470

• Attempt to recover all investigational products from participants (or other sources) at the end of 471 each treatment period. 472 473

Investigational Product Information 474

Adequate investigational product information should be provided to ensure that the health 475

professional can fulfil their duty of care to the participant. Issues of commercial confidence must be 476

considered. Reproduction of any part of a commercially-sponsored protocol or investigator’s 477

brochure is not permissible as a means of providing the required information without approval from 478

the sponsor. 479

The clinical trials pharmacy should have access to the current protocol, Investigator’s Brochure (or 480

equivalent) and pharmacy manual for each clinical trial. 481

Medical, nursing, pharmacy and study staff who will be involved in caring for the participants should 482

have access to information about the investigational medicine(s) being used in the clinical trial. 483

Serious Adverse Event Reporting 484

Serious Adverse Events (SAE) need be reported as per regulatory requirements governed by the TGA 485

and GCP requirements. The clinical trials pharmacist should be familiar with the Australian adverse 486

event reporting system via the TGA and may assist the investigator in detecting and reporting 487

adverse events 5,14. 488

Liaison with clinical pharmacists, medical and nursing staff are encouraged to assist in the early 489

detection of any unexpected clinical trial participant admission to hospital (classified as a serious 490

adverse event)14. The investigator or clinical trial coordinator should be notified as soon as possible. 491

Hospital automatic electronic reporting systems may assist with this process. If clinical trial 492

participants from other institutions are identified, the clinical trials pharmacist/trial coordinator or 493

investigator at that institution should be contacted. 494

Randomisation Codes 495

IWRS systems for randomisation are now most commonly used. For studies not using IWRS a copy of 496

the randomisation code should be retained by the study site or pharmacy in the pharmacy file as 497

appropriate, to allow 24-hour access. The requirements to be met before breaking the code 498

(emergency un-blinding) should be stated clearly to prevent inappropriate breaking of the code. Any 499

premature un-blinding (e.g. accidental or due to a SAE) should be documented and explained to the 500

sponsor by the investigator or clinical trials pharmacist. 501

A record of receipt and return to the sponsor of all randomisation codes should be kept in the 502

Pharmacy File. 503

Confidentiality 504

The confidentiality of the participant and the research must be maintained at all times. Access to 505

pharmacy study records should be provided only to authorised study staff including unblinded 506


monitors and auditors. Compliance with privacy legislation (State and Commonwealth) is mandatory 507 19. 508

Resources 509

The resources recommended for the efficient provision of a clinical trials pharmacy service include: 510

adequate staffing levels (see 511

• Recommended Staffing) 512

• facilities and equipment suitable for appropriate dispensing and compounding and 513 aseptic manufacture of investigational products 514

• sufficient and secure storage space (including refrigeration/freezers) to allow separation 515 of stock for each clinical trial (including medicines returned by participants) with 516 restricted access to clinical trials pharmacy staff 517

• appropriate temperature and humidity control for all clinical trial storage areas including 518 a 24-hour continuous temperature monitoring system 519

• dedicated and secure area with sufficient space for administration and 520 monitoring/auditing of clinical trials as well as for counselling participants on 521 investigational products 522

• space for archiving of records as appropriate 523

• access to information technology including PC, telephone, barcode scanner, printer 524

• access to participant medical records including pathology results as needed 525

• access to a Medicines Information Service 526

• copies of relevant documentation as listed in Appendix 1. 527 528

Recommended Staffing 529

The staffing structure and levels required for a clinical trials pharmacy service will be determined by 530

four major factors; the number of clinical trials undertaken at the institution, the complexity and 531

phase of those clinical trials, and the rate at which new trials are being opened and closed, and 532

patient recruitment. 533

Support staff, under supervision, and with training, may be used for functions such as stock control, 534

computer data entry, manufacturing, and clerical tasks. Qualified pharmacy technicians may assist 535

with dispensing under supervision. 536

In June 2015 the Independent Hospital Pricing Authority (IHPA) released the report Determination of 537

standard costs associated with conducting clinical trials in Australia – Standard list of clinical trial 538

items 26. 539

This report determined the costs for a standard list of items (above those costs for standard care) 540

necessary and associated with conducting clinical trials in Australia. The list of standard items was 541

determined by the National Health and Medical Research Council (NHMRC). These items included 542

services provided by clinical trials pharmacists and the report assigned a standard cost to each of 543

these services. The standard list of items relevant to pharmacy is not limited to the major category 544

of “Pharmacy/ Investigation drug related”. The clinical trials pharmacist should refer to all the major 545

categories and apply the relevant items and the standard cost listed when deciding pharmacy fees. 546

Workload 547

Workload records can help in costing a clinical trials pharmacy and determine staffing levels. Such 548

records could include: 549


• number of dispensing, categorised as, e.g.: 550 o simple dispensing (average dispensing and recording time less than 15 minutes) 551

o standard dispensing 552

o complex dispensing (dispensing and recording time greater than 45 minutes) 553

o sterile preparations 554

o sterile cytotoxic preparations 555

• number of clinical trials opened and closed 556

• monitor visits 557

• details of advice/education given concerning concomitant medications, protocol compliance, 558 dose modifications etc. 559

560

Training and Education (for the service, and of the individual) 561

Training and education of clinical trials pharmacists will predominately be work-based education, 562

should follow adult learning principles, and is documented in Chapter 10. Training and Education of 563

the SHPA Standards of Practice for Clinical Pharmacy Services 1. Clinical trials pharmacists should 564

have an annual learning plan that supports their development and performance along the 565

continuum of advanced practice from transition level (stage 1), to consolidation level (stage 2), and 566

to advanced level (stage 3) 3. Credentialing of advanced practice pharmacists in Australia is provided 567

by Pharmacy Development Australia 27. 568

Pharmacists responsible for medicines which are not currently registered for human use in Australia 569

should have a detailed knowledge of the process of medicines regulation in Australia. 570

Ongoing education and training are important to ensure compliance with the requirements of state 571

and federal legislation and professional standards and guidelines. 572

Pharmacists and pharmacy technicians starting practice in a clinical trial pharmacy service must be 573

provided with an appropriate orientation and training program and be familiar with the documents 574

listed in Appendix 1. 575

Pharmacists in contact with trial participants will need to be knowledgeable about their specific 576

clinical trial protocols. 577

Additional sources of information, training and updates that should be available include: 578

• TGA publications, newsletters and seminars 579

• NHMRC seminars and publications 580

• Speciality Practice in investigational medicines seminars 581

• Speciality Practice in investigational medicines publications (available on SHPA website); 582

• SHPA publications and seminars 583

• Association of Regulatory and Clinical Scientists (ARCS) seminars and newsletters. 584 585

The skills and qualifications for clinical trials pharmacists have to date not been published. The 586

recommended skills and qualifications listed below have been informed by the SHPA Clinical Trials 587

Leadership Committee. 588

Essential skills: 589

• Good Clinical Practice (GCP) training every 3 years 28 590

• Good Manufacturing Practice (GMP) training. 591


Desirable skills: 592

• Knowledge of basic research methodology 593

• A postgraduate qualification in a field related to clinical trials e.g. 594

o Drug development 595

o Credentialing as an Advancing or Advanced Practice Pharmacist. 596

• Training and education in manufacturing of cytotoxic and hazardous substances. 597

Recommendations for education include the following: 598

Domestic: 599

• SHPA Seminars and CPD activities. 600

• Association of Regulatory and Clinical Scientists (ARCS) 601

• Praxis courses 602

• NHMRC eLearning Modules. 603

604

International: 605

• European Association of Hospital Pharmacy (EAHP) Clinical trial regulation 606

• TransCelerate. 607

Educational material and resources are additionally provided on the SHPA Specialty Practice clinical 608

trials stream page on the SHPA eCPD website. For clinical trials pharmacists, joining and actively 609

participating in the SHPA Specialty Practice clinical trials stream at the Practice Group level is 610

strongly recommended. 611

Clinical trial pharmacists should additionally play an active role in the education and training of: 612

• undergraduate pharmacists 613

• pre-registration pharmacists 614

• practising pharmacists involved with clinical trial patients 615

• pharmacy technicians involved with clinical trial patients 616

• research nurses and clinical trial co-ordinators 617

• research data managers 618

• other health professionals involved with clinical trial patients; 619

• to ensure that all these groups are familiar with all the above. 620

Attendance at specialist conferences and educational meetings should be supported to maintain and 621

update specialist knowledge in clinical trials. Relevant domestic conferences include those organised 622

by SHPA, Australian Clinical Trials Alliance (ACTA). International conferences include Association of 623

Regulatory and Clinical Scientists (ARCS). 624

625

Quality Improvement 626

Quality improvement activities should demonstrate that the clinical trials pharmacist is targeting and 627

achieving optimal outcomes for all patient groups, including those at greatest risk for medicines 628

misadventure in addition to advancing the practice of clinical trials. Quality improvement activities 629

may include: 630

• Audit 631

• Performance review against this Standard 632

https://www.arcs.com.au/

http://praxisaustralia.com.au/

https://www.australianclinicaltrials.gov.au/nhmrc-elearning-modules

http://www.clinicaltrialsalliance.org.au/




• Looking at current versus. future state for specific components of clinical trials pharmacy 633

service 634

• Number of papers published per year 635

636

A quality assurance program incorporating pharmacy aspects of clinical trials should be developed 637

and implemented. Quality control should be applied at each stage of data collection to ensure that 638

data is reliable and has been processed correctly. Key performance indicators should be developed 639

for the major components of the service. 640

Suggestions for KPIs may include: 641

• Full Time Equivalent (FTE) budget within 10% of revenue (aim for balanced) reviewed 642 quarterly 643

• Start-up turnaround (from site selection visit [SSV] to site initiation visit [SIV]) 644

• Dispensing statistics (amount of scripts and patient numbers/month) 645

• No. requests for costing quotes (services) 646

• Number of SSVs 647

• Number of SIVs 648

• Uncovered leave (e.g. sick leave) and overtime 649

• Protocol amendments and/or review 650

• Performance at audit. 651

The frequency and duration of data collection and the number of indicators chosen will depend on 652

the size and scope of the pharmacy IMS. 653

Audits should be conducted by persons independent of those responsible for the clinical trial. All 654

data and documentation should be available for inspection by regulatory authorities. 655

A quality improvement program should satisfy the requirements of an accreditation review 29. The 656

following areas could be monitored: 657

• documentation of procedures 658

• completeness and accuracy of drug accountability records and dispensing records 659

• compliance with relevant aspects of the clinical trial protocol 660

• participant counselling/education 661

• assessment of participant compliance 662

• labelling of investigational medicines 663

• temperature recording procedures for storage areas 664

• expiry date checking 665

• procedures for breaking randomisation codes 666

• medicine information and education for staff 667

• recording of interventions and enquiries. 668

The quality of the clinical trial service is enhanced by pharmacist contribution towards ensuring 669

standards of good clinical research practice by involvement in the following activities: 670


• review of protocols prior to ethics committee approval 671

• participation in research or ethics committee discussions 672

• participation in start-up and other trial meetings 673

• regular liaison with investigators, data managers and research nurses. 674

Further information on quality improvement can be found in Chapter 14 of the SHPA Standards of 675

Practice for Clinical Pharmacy Services 1. 676

677

Research 678

Clinical trials pharmacists are encouraged to participate in and contribute towards advancing the 679

knowledge and evidence of investigational products and clinical trial research. Clinical trials 680

pharmacists are likely to be well positioned with opportunities for research, particularly with 681

investigator-driven studies where investigators may approach the trials pharmacist for advice, 682

resources and solutions to address challenging clinical trial or investigational drug issues. It is 683

advisable to clarify and establish upfront if the work and services provided by the clinical trials 684

pharmacist means an invitation for formal collaboration on clinical trial protocols and grants (e.g. co-685

investigator status, authorship on publications etc.). There are many areas where clinical trials 686

pharmacists can significantly contribute to collaborative research, including the following: 687

• advice in clinical trial design, and stratification of treatment arms 688

• design, generation and implementation of randomisation schedules 689

• innovation and formulation of blinded dose forms (e.g. drug encapsulation, blinded aseptic 690

products) 691

• assessing the chemical stability of drugs in investigational or off-label formulations. 692

External funding enables larger and possibly multi-centre studies to be conducted. The SHPA 693

National Translational Research Collaborative (NTRC) funds research grants, practitioner grants and 694

educational grants. Presentation and publication of studies by Australian pharmacists practising in 695

clinical trials are imperative, to aid others and to illustrate where clinical trials pharmacists are 696

involved in research and how they are improving patient care. 697

The choice of journal to publish in depends on consideration of the best audience for the study 698

results. The Journal of Pharmacy Practice and Research (JPPR) presents findings to primarily an 699

Australian pharmacy audience. 700

Further information on research can be found in Chapter 11 of the SHPA Standards of Practice for 701

Clinical Pharmacy Services 1. 702

703

Acknowledgements 704

The SHPA additionally wish to acknowledge the work of the former SHPA Committee of Specialty 705

Practice in Investigational Drugs on previous versions of this Standard Kay Hynes, Jillian Davis, Helen 706

Kopp, Angela Morris, Carol Rice and Helen Matthews as well as Eugenia Hong, Michael Ching, Peta 707

Breitag and Mei Grant of the former SHPA Committee of Specialty Practice in Investigational Drugs 708

who contribution to a previous draft of this Standard. 709


710

References 711

1. SHPA Committee of Specialty Practice in Clinical Pharmacy. SHPA Standards of Practice for 712 Clinical Pharmacy Services. Journal of Pharmacy Practice and Research 2013; 43(No. 2 713 Supplement): S1-69. 714

2. SHPA Committee of Specialty Practice in Investigational Drugs. SHPA Standards of Practice for 715 Pharmacy Investigational Drugs Services. 2006. 716

3. Pharmaceutical Society of Australia. National Competency Standards Framework for 717 Pharmacists in Australia. Deakin West ACT 2600; 2016. 718

4. The Australian Commission on Safety and Quality in Health Care. Australian Charter of 719 Healthcare Rights. 2008. 720

5. Therapeutic Goods Administration. ICH Guideline for Good Clinical Practice-Annotated with 721 TGA comments. 2018. https://www.tga.gov.au/publication/note-guidance-good-clinical-722 practice. 723

6. World Medical Association. Declaration of Helsinki – Ethical Principles for Medical Research 724 Involving Human Subjects. Brazil: World Medical Association; 2013. 725

7. Australian Commission on Safety and Quality in Health Care. National Safety and Quality 726 Health Service Standards. Medication Safety. Sydney: Australian Commission on Safety and 727 Quality in Health Care; 2017. p. 86. 728

8. Australian Commission on Safety and Quality in Health Care. National Model Clinical 729 Governance Framework. Sydney, NSW; 2017. 730

9. Pharmacy Board of Australia. For Pharmacists Code of Conduct. March 2014 ed; 2014. 731 10. The Society of Hospital Pharmacists Australia. SHPA Code of Ethics. Governance. Collingwood: 732

The Society of Hospital Pharmacists of Australia; 2016. p. 1. 733 11. Pharmaceutical Society of Australia. Professional Practice Standards Version 5. Deakin West 734

ACT 2600.; 2017. p. 116. 735 12. Pharmaceutical Society of Australia. Clinical Governance Principles for Pharmacy Services 736

2018. Deakin West, ACT, Australia: Pharmaceutical Society of Australia, 2018. 737 13. Privacy Act 1988. Compilation No 80. Australia: Office of Parliamentary Counsel, Canberra; 738

2018. p. 380. 739 14. Therapeutic Goods Administration. Access to unapproved therapeutic goods - Clinical trials in 740

Australia. ACT; 2004. 741 15. Therapeutic Goods Administration. Australian clinical trial handbook: Guidance on conducting 742

clinical trials in Australia using ‘unapproved’ therapeutic goods. In: Health Do, editor.; 2018. 743 16. National Health and Medical Research Council, Australian Research Council, Universities 744

Australia. National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). 745 2018. 746

17. National Health and Medical Research Council. Australian Code for Responsible Conduct of 747 Research. 2018. 748

18. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation 749 Scheme. Guide to Good Manufacturing Practice for Medicinal Products - Annex 13 - 750 Manufacture of investigational medicinal products. 2017. 751

19. National Health and Medical Research Council. The regulation of health information privacy in 752 Australia. 2004. 753

20. SHPA Manufacturing Working Party. SHPA Guidelines for Medicines Prepared in Australian 754 Hospital Pharmacy Departments. 2010. 755

21. SHPA Committee of Specialty Practice in Oncology. SHPA Standards of Practice for the Safe 756 Handling of Cytotoxic Drugs in Pharmacy Departments. Journal of Pharmacy Practice & 757 Research 2005; 35(1): 44-52. 758

https://www.tga.gov.au/publication/note-guidance-good-clinical-practice

https://www.tga.gov.au/publication/note-guidance-good-clinical-practice


22. SHPA Committee of Specialty Practice in Cancer Services. SHPA Standards of Practice for the 759 Transportation of Cytotoxic Drugs from Pharmacy Departments. Journal of Pharmacy Practice 760 & Research 2007; 37(3): 234-5. 761

23. Alexander M, King J, Bajel A, et al. Australian consensus guidelines for the safe handling of 762 monoclonal antibodies for cancer treatment by healthcare personnel. Intern Med J 2014; 763 44(10): 1018-26. 764

24. Booth J, Keith C, Tanner F, Siderov J, Aminian P. Hazardous non-cytotoxic medicines: 765 uncertainty around safe handling? A new workplace guideline for hospital staff. Journal of 766 Pharmacy Practice and Research 2018. 767

25. Power LA, Polovich M. Safe Handling of Hazardous Drugs: Reviewing Standards for Worker 768 Protection. PHARMACY PRACTICE NEWS 2018; (SE2018): 16-28. 769

26. Independent Hospital Pricing Authority. Determination of standard costs associated with 770 conducting clinical trials in Australia- Standard List of Clinical Trial Items. In: Independent 771 Hospital Pricing Authority, editor.; 2015. 772

27. Pharmacy Development Australia. Advancing Practice Background and Guiding Principles, 773 2018. 774

28. TransCelerate. GCP Mutual Recognition. 2019. 775 https://www.transceleratebiopharmainc.com/gcp-training-attestation/ (accessed 27/05/2019 776 2019). 777

29. Australian Commision on Safety and Quality in Health Care. Clinical Trials. 2019. 778 https://www.safetyandquality.gov.au/our-work/clinical-trials/ (accessed 27/05/2019 2019). 779

30. Therapeutic Goods Administration. Special Access Scheme: Guidance for health practitioners 780 and sponsors. ACT; 2017. 781

31. Therapeutic Goods Administration. Human Research Ethics Committees and the Therapeutic 782 Goods Legislation. In: Department of Health and Aged Care, editor.; 2001. 783

32. National Health and Medical Research Council. Ethical conduct in research with Aboriginal and 784 Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders. 785 Canberra: Commonwealth of Australia:,, 2018. 786

33. (EAHP) EAoHP. EAHP Statement on Clinical Trials. 2012. p. 4. 787

788

https://www.transceleratebiopharmainc.com/gcp-training-attestation/

https://www.safetyandquality.gov.au/our-work/clinical-trials/


Appendices 789

Appendix 1: Resources 790

Resource documents required for use

• Therapeutic Goods Administration. ICH Harmonised Guideline. Integrated Addendum to ICH

E6(R1): Guideline for Good Clinical Practice-Annotated with TGA comments 2018 5

• Australian clinical trial handbook: Guidance on conducting clinical trials in Australia using

'unapproved' therapeutic goods ACT 2018 15

• NHMRC National Statement on Ethical Conduct in Human Research 16

• Protocols and investigators brochures/TGA approved product information for all clinical trials;

• Access to unapproved therapeutic goods - the special access scheme (SAS) 30

• Human research ethics committee and the therapeutic goods legislation 15,31

• NHMRC. Values and ethics: guidelines for ethical conduct in aboriginal and Torres Strait

islander health research 32

Additional documents that may be of use

• European Association of Hospital Pharmacists (EAHP) Statement on Clinical Trials 201233

Useful Websites

Australian clinical trial handbook https://www.tga.gov.au/publication/australian-

clinical-trial-handbook

Special Access Scheme (SAS): Online system

guidance

https://www.tga.gov.au/publication/special-

access-scheme-sas-online-system-guidance

European Medicines Agency (EMA) Clinical Trial

Regulation

https://www.ema.europa.eu/en/human-

regulatory/research-development/clinical-

trials/clinical-trial-regulation

791

Appendix 2: Definitions 792

Clinical Trial Terms Definition Purpose

AE: Adverse Event Any undesired action or effect

of an investigational medicine

that occurs during or within a

proscribed period of time

after a trial has ended

Clinical Trial/Clinical Study A planned study in humans To investigate and report

upon the safety and/or

effectiveness of a diagnostic,

therapeutic or prophylactic

medicine

https://www.tga.gov.au/publication/australian-clinical-trial-handbook

https://www.tga.gov.au/publication/special-access-scheme-sas-online-system-guidance

https://www.tga.gov.au/publication/special-access-scheme-sas-online-system-guidance


Phase I Study 14 A study which involves the

first administration of the

medicine in humans.

Usually administered to

healthy volunteers however

for certain medicine classes

such as cytotoxic medicines

may be conducted in patients

suffering from the condition

the medicine is intended to

treat

To determine the safety of the

medicine, its pharmacological

activity, pharmacokinetics and

tolerance. It may also identify

routes of administration and

appropriate doses.

Phase II study 14 First trial of the medicine in a

small number of closely

supervised patients suffering

from the condition for which

the medicine is intended

To determine efficacy and

safety, therapeutic dose range

and maximum tolerated dose

of the medicine

Phase III study 14 Extended clinical trials in

greater numbers of patients

To generate clinical efficacy

data and determine incidence

and nature of adverse events

Phase IV study 14 Post marketing studies To compare the medicine to a

wider range of therapies and

further investigate the use of

the medicine in the normal

clinical setting

CTX: Clinical Trial Exemption

Scheme for Medicines 14

A sponsor submits an

application to conduct a

clinical trial to the TGA for

evaluation and comment

Notification under CTX or CTN

is required for clinical

investigation of

a) Any medicine not entered in the Australian Register for Therapeutic goods (ARTG)

b) Any use of a marketed medicine beyond the conditions of its marketing approval

CTN: Clinical Trial Notification

Scheme 14

The sponsor notifies the TGA

that a clinical trial is to be

conducted. The HREC takes

responsibility for the review of

the data

GCP: Good Clinical Practice 5 A standard for the design,

conduct, performance,

monitoring, auditing,

recording, analysis and

reporting of clinical trials

To provide assurance that the

data and reported results are

credible and accurate and that

the rights, integrity and

confidentiality of the trial

participants are protected

HREC: Human Research Ethics

Committee16

An institutional committee

whose composition and

To evaluate and monitor the

conduct of clinical trials


function is consistent with the

National Statement on Ethical

Conduct in Human Research

and has notified its existence

to the Australian Health Ethics

Committee

conducted within an

institution

Investigational product Any medicine, reference

product or placebo which is

being tested or used as a

reference in a clinical trial

This may include a TGA-

registered medicine used in a

different formulation or used

for an unapproved indication

or in doses outside the

approved range

Investigator 5 A person responsible for the

conduct of a clinical trial at a

trial site.

Principal Investigator 5 The responsible leader of a

team of investigators of a

clinical trial at a trial site

Investigator’s Brochure 5 A compilation of the clinical

and non-clinical data on the

investigational medicine(s)

which is relevant to the study

of the investigational

medicine(s) in human subjects

Protocol 5 A document which describes

the rationale, objectives,

study design, identification of

subjects, methodology,

assessments, evaluation,

ethical compliance and

dissemination of results of a

clinical trial

To direct the conduct and

evaluation of a clinical trial

Serious Adverse Event (SAE) Serious Adverse Event (SAE)

or Serious Adverse Drug

Reaction (Serious ADR) Any

untoward medical occurrence

that at any dose: - results in

death, - is life-threatening, -

requires inpatient

hospitalization or

prolongation of existing

hospitalization, - results in

persistent or significant

disability/incapacity, or - is a


congenital anomaly/birth

defect (see the ICH Guideline

for Clinical Safety Data

Management: Definitions and

Standards for Expedited

Reporting).

Suspected Unexpected

Serious Adverse Reaction

(SUSAR)

Sometimes during a clinical

trial for a certain drug, a

subject may experience

serious adverse reactions that

may or may not be dose-

related but are unexpected, as

they are not consistent with

current information.

793

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