synopsis - admin.ox.ac.uk web viewsop. standard operating procedure. ... example: participants will...

Protocol version number and date: Insert

Information on OxTREC Full Committee Protocol Template – please read before starting

This template is available for use by all investigators who are submitting an application to OxTREC for full committee review.

The purpose of this document is to guide researchers to consider all aspects of the study. The protocol should be a document that describes the objectives, design, methodology, statistical considerations and organisation of a research study.

You can adapt this template or use your own document and formatting. However, you should consider the items below.

All guidance text is highlighted in yellow/blue. This should be deleted before finalising the document.

Note that some of the sections of this template may not apply to your study and may be deleted.

Please delete this instruction cover sheet before finalising the document.

Should you require any assistance, please contact the OxTREC Secretariat: [email protected].

https://researchsupport.admin.ox.ac.uk/governance/ethics/apply/oxtrec

OxTREC full committee protocol template version 2/8/17

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https://researchsupport.admin.ox.ac.uk/governance/ethics/apply/oxtrec

mailto:[email protected]


Study Title: insert full title

Internal Reference Number / Short title: This should be assigned by the investigator/department (may be deleted if not required)

OxTREC Ref: Insert

Date and Version No: Insert

Chief Investigator: Insert name and contact details, including institutional affiliation

Investigators: Insert names of key collaborators, including institutional affiliations

Sponsor: Insert name of organisation sponsoring the study

Funder: Insert details of organisation providing funding

Chief Investigator Signature: The approved protocol should be signed by author(s) and/or person(s) authorised to sign the protocol

Please declare any potential conflicts of interest.

Confidentiality Statement

This document contains confidential information that must not be disclosed to anyone other than the authorised individuals from the University of Oxford, the Investigator Team and members of the Oxford Tropical Research Ethics Committee (OxTREC), unless authorised to do so.


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TABLE OF CONTENTS

To update table of contents (TOC), hover cursor over the table and ‘right click’. Choose ‘update field’, then ‘update entire table’.

1. SYNOPSIS..............................................................................................................................................5

2. ABBREVIATIONS....................................................................................................................................5

3. BACKGROUND AND RATIONALE...........................................................................................................5

4. OBJECTIVES AND OUTCOME MEASURES..............................................................................................6

5. STUDY DESIGN......................................................................................................................................7

6. PARTICIPANT IDENTIFICATION AND RECRUITMENT.............................................................................7

6.1. Study Participants.........................................................................................................................7

6.2. Inclusion Criteria...........................................................................................................................7

6.3. Exclusion Criteria..........................................................................................................................8

7. STUDY PROCEDURES.............................................................................................................................8

7.1. Recruitment..................................................................................................................................8

7.2. Screening and Eligibility Assessment............................................................................................8

7.3. Informed Consent.........................................................................................................................8

7.4. Randomisation, blinding and code-breaking................................................................................9

7.5. Baseline Assessments...................................................................................................................9

7.6. Subsequent Visits.........................................................................................................................9

7.7. Sample Handling...........................................................................................................................9

7.8. Discontinuation/Withdrawal of Participants from Study............................................................10

7.9. Definition of End of Study...........................................................................................................10

8. INTERVENTIONS / INVESTIGATIONS (IF APPLICABLE).........................................................................10

9. INVESTIGATIONAL MEDICINAL PRODUCT (IMP) (FOR CLINICAL TRIALS ONLY)...................................11

9.1. IMP Description..........................................................................................................................11

9.2. Storage of IMP............................................................................................................................11

9.3. Compliance with Trial Treatment...............................................................................................11

9.4. Accountability of the Trial Treatment.........................................................................................11

9.5. Concomitant Medication............................................................................................................11

9.6. Post-trial Treatment...................................................................................................................11

10. SAFETY REPORTING (IF APPLICABLE)..............................................................................................11

10.1. Definition of Serious Adverse Events......................................................................................12

10.2. Reporting Procedures for Serious Adverse Events..................................................................12


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11. SAFETY REPORTING (SPECIFICALLY FOR CLINICAL TRIALS)..............................................................12

11.1. Definitions..............................................................................................................................12

11.2. Causality.................................................................................................................................14

11.3. Procedures for Recording Adverse Events..............................................................................14

11.4. Reporting Procedures for Serious Adverse Events..................................................................14

11.5. Expectedness..........................................................................................................................15

11.6. SUSAR Reporting.....................................................................................................................15

11.7. Safety Monitoring Committee................................................................................................15

11.8. Development Safety Update Reports.....................................................................................15

12. STATISTICS AND ANALYSIS..............................................................................................................15

12.1. Description of Statistical Methods..........................................................................................15

12.2. The Number of Participants....................................................................................................16

12.3. Analysis of Outcome Measures...............................................................................................16

13. DATA MANAGEMENT.....................................................................................................................16

13.1. Access to Data........................................................................................................................16

13.2. Data Handling and Record Keeping........................................................................................16

14. QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURES........................................................16

15. ETHICAL AND REGULATORY CONSIDERATIONS..............................................................................16

15.1. Declaration of Helsinki............................................................................................................16

15.2. Guidelines for Good Clinical Practice......................................................................................16

15.3. Approvals................................................................................................................................17

15.4. Participant Confidentiality......................................................................................................17

15.5. Expenses and Benefits............................................................................................................17

15.6. Reporting................................................................................................................................17

15.7. Other Ethical Considerations..................................................................................................17

16. FINANCE AND INSURANCE..............................................................................................................17

16.1. Funding...................................................................................................................................17

16.2. Insurance................................................................................................................................17

17. PUBLICATION POLICY......................................................................................................................18

18. REFERENCES...................................................................................................................................19

19. APPENDIX A: STUDY FLOW CHART.................................................................................................20

20. APPENDIX B: SCHEDULE OF STUDY PROCEDURES..........................................................................21

21. APPENDIX C: AMENDMENT HISTORY.............................................................................................22


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1. SYNOPSISIt may be useful to include a brief synopsis of the study for quick reference. Complete information and, if required, add additional rows.

Study Title

Internal ref. no. (if applicable)

Study Design

Study Participants

Planned Sample Size

Planned Study Period

Objectives Outcome Measures

Primary

Secondary

2. ABBREVIATIONSDefine all unusual or ‘technical’ terms related to the project. Add or delete as appropriate to your study. Maintain alphabetical order for ease of reference.

CI Chief Investigator

CRF Case Report Form

CUREC Central University Research Ethics Committee

GCP Good Clinical Practice

ICF Informed Consent Form

OxTREC Oxford Tropical Research Ethics Committee

PI Principal Investigator

PIS Participant Information Sheet

SOP Standard Operating Procedure

3. BACKGROUND AND RATIONALEInclude the following:

Brief background to the study, including scientific justification for the research.


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Outline of the main research questions.

Brief description of the intervention (if applicable).

Summary of findings from previous studies (if relevant) that potentially have significance. State any assumptions you are making, and any limitations to the project.

Summary of the known and potential risks and benefits, if any, to human participants.

Description of the population to be studied & the population whom the results of the project might be generalised to.

References to literature and data that are relevant to the study and that provide background for the study.

4. OBJECTIVES AND OUTCOME MEASURESThere is usually only one primary objective, the rest are secondary objectives.

The wording of the objectives should be clear, unambiguous and as specific as possible – the study will be judged on how, and how well, the objectives were satisfied. Complete table below with all relevant information.

Please ensure these match with those stated on the OxTREC application form.

Objectives Outcome Measures Timepoint(s) of evaluation of this outcome measure (if applicable)

Primary ObjectiveWhat question(s) are you trying to answer? Reviewers pay particular attention to the purpose of research, asking "What question is the research asking, is it worth asking and can it be answered?” Your answers should be succinct, excluding methodology, and realistic.

Example: To compare the effect of treatment A versus treatment B on the levels of protein X in the blood.

Describe the outcome measures and how/when they will be measured during the study.

Outcome measures should reflect the objectives. It is important that only one outcome measure is selected as it will be used to decide the overall results or ‘success’ of the study. The primary outcome measure should be measurable, clinically relevant to participants and widely accepted by the scientific and medical community.

Assessments of outcome measures should be described in detail in section 7.

Example: Blood sampling at day 0 and day 28 post-treatment

Secondary ObjectivesWhat other question(s) are you trying to answer? Reviewers pay

As above


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particular attention to the purpose of research, asking "What question is the research asking, is it worth asking and can it answer it?". Your answers should be succinct, excluding methodology, and realistic.

Example: To assess the safety of treatment A in <insert condition/population>

Tertiary ObjectivesPlease add if applicable

As above

5. STUDY DESIGNSummarise the overall study design e.g. double-blind, placebo-controlled, parallel design, open labelled, observational. Avoid repetition as full details will be given in later sections.

Give the expected duration of participant participation, number of visits, a description of the sequence and duration of all study periods e.g. screening, study procedure(s), post-procedure(s) follow-up.

Describe processes for collecting data, and why this method will be used (e.g. type of equipment, questionnaire, interview schedule, observation schedule).

Include a timetable for the project (as an appendix), if appropriate.

6. PARTICIPANT IDENTIFICATION AND RECRUITMENT

6.1. Study ParticipantsGive an overall description of the study participants.

Example:

Healthy volunteers aged <insert age>.

6.2. Inclusion CriteriaExample criteria only (amend as appropriate):

Participant is willing and able to give informed consent for participation in the study. Healthy adults, Male or Female, aged 18 to 60 years. Not currently taking any medications (except the contraceptive pill). Additional study specific criteria as required.


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6.3. Exclusion CriteriaExample criteria only (amend as appropriate):

The participant may not enter the study if ANY of the following apply:

Specify any diseases/disorders/ conditions that would preclude entry into the study. Pregnant or breast feeding History or current psychiatric illness History or current neurological condition (e.g. epilepsy) Additional study specific criteria as required.

7. STUDY PROCEDURESDescribe all study procedures and assessments in detail in the sections below, or change sections as necessary. Add visit numbers as appropriate.

Add schedule of procedures as an appendix, if appropriate.

7.1. RecruitmentDescribe how potential participants will be identified, approached, screened and recruited.

Example: Participants will be recruited by word of mouth, emails to departmental mailing lists and posters located in University Departments.

7.2. Screening and Eligibility AssessmentSpecify the maximum duration allowed between screening and recruitment (if applicable).

Describe the screening procedures in detail. If applicable, specify pre-screening procedures such as demographics, medical history and physical examination.

If any screening procedures (such as blood sampling) require prior informed consent, then this section should be moved to between ‘Informed Consent’ and ‘Randomisation’.

7.3. Informed ConsentYou need to specify who will take informed consent, how and when it will be taken. Informed Consent must be obtained prior to any study related procedures being undertaken.

Example:

The participant must personally sign and date the latest approved version of the Informed Consent form before any study specific procedures are performed.

Written and verbal versions of the Participant Information and Informed Consent will be presented to the participants detailing no less than: the exact nature of the study; what it will involve for the participant; the implications and constraints of the protocol; the known side effects and any risks involved in taking part. It will be clearly stated that the participant is free to withdraw from the study at


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any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.

The participant will be allowed as much time as wished to consider the information, and the opportunity to question the Investigator or other independent parties to decide whether they will participate in the study. Written Informed Consent will then be obtained by means of participant dated signature and dated signature of the person who presented and obtained the Informed Consent. The person who obtained the consent must be suitably qualified and experienced, and have been authorised to do so by the Chief Investigator. A copy of the signed Informed Consent will be given to the participant. The original signed form will be retained at the study site.

7.4. Randomisation, blinding and code-breakingIf applicable, describe how randomisation and blinding are going to be carried out, and when (otherwise delete this section).

If relevant, describe the procedure for code-breaking.

If participants will not be randomised, please delete this section entirely.

7.5. Baseline AssessmentsSpecify and describe all baseline assessments. They must reflect the objectives and outcome measures.

If there will only be one study visit, this section should be renamed ‘Study Visit’ and full details of this visit be included. The next section ‘Subsequent Visits’ can then be deleted.

7.6. Subsequent VisitsSpecify when participants will be followed up and what assessments will be conducted. Specify if they are visits, telephone assessments, or home visits by the study staff. Add visit numbers and window periods if applicable. Clearly number these visits.

For each visit (including baseline), consider inclusion of the following, where appropriate:

eligibility check assessment of outcome measures assessments of safety including general (e.g. physical examination), specific safety assessments

(e.g. adverse event collection) dispensing of study product assessment of compliance with study product recording of concomitant medications (if applicable)

Provide a detailed description of each of the assessments to be carried out

7.7. Sample HandlingIf not mentioned previously, describe the samples that will be taken from each participant (e.g. blood, urine, tissue), the volume of sample, and the frequency of sampling. Give brief details as to how the sample will be processed and stored once taken, who will have access (i.e. study team only for this


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project, or will it be stored long-term for use in future ethically approved studies), and duration of storage. Provide an overview of the laboratory analyses that will be performed.

If no samples will be taken, please delete this section entirely.

7.8. Discontinuation/Withdrawal of Participants from Study

Example:

Each participant has the right to withdraw from the study at any time. In addition, the Investigator may discontinue a participant from the study at any time if the Investigator considers it necessary for any reason including:

Delete/add as appropriate

Pregnancy Ineligibility (either arising during the study or retrospectively having been overlooked at

screening) Significant protocol deviation Significant non-compliance with treatment regimen or study requirements Withdrawal of Consent Loss to follow up

Specify any procedures and observations that will continue to be required until the end of the study. Why will this be necessary?

State whether withdrawal from the study will result in exclusion of the data for that participant from analysis.

State whether or not withdrawn participants will be replaced.

The reason for withdrawal will be recorded in the Case Report Form.

7.9. Definition of End of StudyThe definition of end of study must be provided. In most cases the end of study will be the date of the last visit of the last participant. Any exceptions should be justified.

Example:

The end of study is the date of the last visit / telephone follow up / home visit of the last participant.

8. INTERVENTIONS / INVESTIGATIONS (IF APPLICABLE)If your study is a clinical trial, complete section 9 below instead.

If there are no interventions, then delete this section.

Describe any intervention(s), including the name(s) of procedure/device, schedule(s), treatment period(s), if applicable.


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N.B. Interventions are procedures that affect physiology and include administration of a drug or surgical procedures.

9. INVESTIGATIONAL MEDICINAL PRODUCT (IMP) (FOR CLINICAL TRIALS ONLY)If your study is not a clinical trial, then delete this section. Consider section 8 above instead.

9.1. IMP DescriptionName and describe the trial treatment(s) including placebo if used.

Briefly describe the dosage, and administration of trial medications.

Briefly describe the dosage form, packaging, and labelling of the trial treatment(s).

9.2. Storage of IMPDescribe the storage arrangements and required storage conditions of the trial treatment. Will it be stored in the pharmacy? If not using the pharmacy, describe the conditions for storage and any procedures for checking that appropriate temperatures are maintained etc.

9.3. Compliance with Trial TreatmentYou need to describe how compliance is assessed, and how it will be defined for the trial (e.g. 80% doses taken). Will you ask the participants to keep a diary, bring all unused or part-used medication/vials and packaging from used medication at each visit? You may want to define significant non-compliance and what procedures will be taken if there is significant non-compliance.

9.4. Accountability of the Trial TreatmentDescribe how medication including placebo will be accounted for.

If a marketed comparator is to be used, describe how it will be administered.

9.5. Concomitant MedicationList any contraindicated medications and check that they correspond with the exclusion and withdrawal criteria.

9.6. Post-trial TreatmentState if there will or will not be provision of the IMP beyond the trial period.

10. SAFETY REPORTING (IF APPLICABLE)If your study is a clinical trial, complete section 11 below instead.

Consider whether the study methodology, interventions or investigations may be associated with any serious adverse events.


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If yes, then include this section, otherwise remove.

10.1. Definition of Serious Adverse EventsA serious adverse event is any untoward medical occurrence that:

results in death

is life-threatening

requires inpatient hospitalisation or prolongation of existing hospitalisation

results in persistent or significant disability/incapacity

consists of a congenital anomaly or birth defect.

Other ‘important medical events’ may also be considered serious if they jeopardise the participant or require an intervention to prevent one of the above consequences.

NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.

10.2. Reporting Procedures for Serious Adverse EventsExample:

A serious adverse event (SAE) occurring to a participant should be reported to the relevant local authorities following local reporting requirements and timelines <insert details> where, in the opinion of the Chief Investigator, the event was ‘related’ (resulted from administration of any of the research procedures) and ‘unexpected’ (the type of event is not listed in the protocol as an expected occurrence).

11. SAFETY REPORTING (SPECIFICALLY FOR CLINICAL TRIALS)If your study is not a clinical trial, then delete this section. You should consider section 10 above instead.

11.1. Definitions

Adverse Event (AE) Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product.

Adverse Reaction (AR) An untoward and unintended response in a participant to an investigational medicinal product which is related to any dose administered to that participant.

The phrase "response to an investigational medicinal product" means that a causal relationship between a trial medication and an AE is at least a reasonable possibility, i.e. the relationship cannot be ruled out.

All cases judged by either the reporting medically qualified professional


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or the Sponsor as having a reasonable suspected causal relationship to the trial medication qualify as adverse reactions.

Serious Adverse Event (SAE)

A serious adverse event is any untoward medical occurrence that:

results in death is life-threatening requires inpatient hospitalisation or prolongation of existing

hospitalisation results in persistent or significant disability/incapacity consists of a congenital anomaly or birth defect.

Other ‘important medical events’ may also be considered serious if they jeopardise the participant or require an intervention to prevent one of the above consequences.

NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.

Serious Adverse Reaction (SAR)

An adverse event that is both serious and, in the opinion of the reporting Investigator, believed with reasonable probability to be due to one of the trial treatments, based on the information provided.

Suspected Unexpected Serious Adverse Reaction (SUSAR)

A serious adverse reaction, the nature and severity of which is not consistent with the information about the medicinal product in question set out:

in the case of a product with a marketing authorisation, in the summary of product characteristics (SmPC) for that product

in the case of any other investigational medicinal product, in the investigator’s brochure (IB) relating to the trial in question.

NB: to avoid confusion or misunderstanding of the difference between the terms “serious” and “severe”, the following note of clarification is provided: “Severe” is often used to describe intensity of a specific event, which may be of relatively minor medical significance. “Seriousness” is the regulatory definition supplied above.

Any pregnancy occurring during the clinical trial and the outcome of the pregnancy should be recorded and followed up for congenital abnormality or birth defect, at which point it would fall within the definition of “serious”.

11.2. CausalityThe relationship of each adverse event to the trial medication must be determined by a medically qualified individual according to the following definitions:


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Related: The adverse event follows a reasonable temporal sequence from trial medication administration. It cannot reasonably be attributed to any other cause.

Not Related: The adverse event is probably produced by the participant’s clinical state or by other modes of therapy administered to the participant.

11.3. Procedures for Recording Adverse EventsConsider whether all non-serious AEs need to be recorded, taking into account the safety profile of the IMP i.e. if the safety profile of the IMP is very well known then you may not need to record all AEs. If you decide not to record non-serious AEs then state this and provide justification for not doing so. If AEs are to be recorded, consider adapting text below as appropriate:

All AEs occurring during the trial / or until < Insert appropriate time period during which AEs will be recorded> that are observed by the Investigator or reported by the participant, will be recorded on the CRF, whether or not attributed to trial medication.

The following information will be recorded: description, date of onset and end date, severity, assessment of relatedness to trial medication, other suspect drug or device and action taken. Follow-up information should be provided as necessary.

The severity of events will be assessed on the following scale: 1 = mild, 2 = moderate, 3 = severe.

AEs considered related to the trial medication as judged by a medically qualified investigator or the Sponsor will be followed either until resolution, or the event is considered stable.

It will be left to the Investigator’s clinical judgment to decide whether or not an AE is of sufficient severity to require the participant’s removal from treatment. A participant may also voluntarily withdraw from treatment due to what he or she perceives as an intolerable AE. If either of these occurs, the participant must undergo an end of trial assessment and be given appropriate care under medical supervision until symptoms cease, or the condition becomes stable.

11.4. Reporting Procedures for Serious Adverse EventsInsert appropriate time period during which SAEs will be recorded. For example, from taking of Informed Consent to 30 days following last administration of IMP. This will, of course, depend on the nature of the IMP, etc.

If the trial is multicentre, you need to consider the coordination of SAE reporting for the whole trial.

N.B. Foreseeable and predefined SAEs do not need to be reported immediately, e.g. if hospital admission/death is expected in the underlying condition, and this has been stated in the protocol.

Provide details of reporting procedures for SAEs. Include reporting timelines, what will happen to the SAEs on receipt, who will review once reported, and who will assess expectedness?

Review of SAEs must be timely, taking into account the reporting time for a potential SUSAR.

11.5. Expectedness


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Expectedness will be determined according to the Investigators’ Brochure/Summary of Product Characteristics. (delete as appropriate)

11.6. SUSAR ReportingAll SUSARs will be reported by the CI to the relevant Competent Authority and to the Ethics Committee and other parties as applicable. For fatal and life-threatening SUSARS, this will be done no later than 7 calendar days after the Sponsor or delegate is first aware of the reaction. Any additional relevant information will be reported within 8 calendar days of the initial report. All other SUSARs will be reported within 15 calendar days.

Treatment codes will be un-blinded for specific participants.

Principal Investigators will be informed of all SUSARs for the relevant IMP for all studies with the same Sponsor, whether or not the event occurred in the current trial.

11.7. Safety Monitoring Committee

Provide details of the trial safety monitoring committee here.

11.8. Development Safety Update ReportsWhere appropriate, the IMP manufacturer should be encouraged to submit Development Safety Update Reports (DSURs). However, in the absence of this

Either

<Name of Company> will submit DSURs once a year throughout the clinical trial, or on request to the Competent Authority, Ethics Committee, and Sponsor.

Or

the CI will submit (in addition to the expedited reporting above) DSURs once a year throughout the clinical trial, or on request, to the Competent Authority, Ethics Committee, and Sponsor.

12. STATISTICS AND ANALYSISThe sub-headings given below are suggestions. Add/delete as appropriate.

12.1. Description of Statistical MethodsDescribe the statistical methods to be employed, including timing of any planned interim analysis(es).

12.2. The Number of ParticipantsState the approximate number of participants required to complete (commence). Justify choice of sample size, including reflections on (or calculations of) the power of the study. It is the primary outcome that determines the sample size needed. Take into account any potential withdrawals.


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12.3. Analysis of Outcome MeasuresDescribe analysis of primary and secondary outcome measures. Include details as to which participant data will be used (e.g. all participants, including/excluding those that withdrew consent).

13. DATA MANAGEMENT

13.1. Access to DataDirect access will be granted to authorised representatives from the University of Oxford and any host institution for monitoring and/or audit of the study to ensure compliance with regulations.

13.2. Data Handling and Record KeepingDescribe method of data entry/management

Example:

All study data will be entered on a <quote software and validation procedure e.g. Excel spreadsheet>. The participants will be identified by a unique study specific number and/or code in any database. The name and any other identifying detail will NOT be included in any study data electronic file.

14. QUALITY CONTROL AND QUALITY ASSURANCE PROCEDURESIf required, provide details of how data monitoring and other quality control measures will be performed. Example:

The study will be conducted in accordance with relevant regulations and standard operating procedures.

15. ETHICAL AND REGULATORY CONSIDERATIONS

15.1. Declaration of HelsinkiThe Investigator will ensure that this study is conducted in accordance with the principles of the Declaration of Helsinki. NB. The 2008 Declaration of Helsinki provides detail on what must be included in a protocol: funding, sponsorship, affiliations and potential conflicts of interest, incentives to participate and compensation for harm.

15.2. Guidelines for Good Clinical PracticeThe Investigator will ensure that this study is conducted in accordance with relevant regulations and with Good Clinical Practice.

15.3. ApprovalsConsider the following text:


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The protocol, informed consent form, participant information sheet and any proposed advertising material will be submitted to OxTREC and local ethics committees for written approval.

The Investigator will submit and, where necessary, obtain approval from the above parties for all amendments to the original approved documents.

15.4. Participant ConfidentialityExample:

The study staff will ensure that the participants’ anonymity is maintained. The participants will be identified only by a participant ID number on all study documents and any electronic database, with the exception of the CRF, where participant initials may be added. All documents will be stored securely and only accessible by study staff and authorised personnel. The study will comply with the Data Protection Act, which requires data to be anonymised as soon as it is practical to do so.

15.5. Expenses and BenefitsDetail all intended payments to participants and any other benefits (Declaration of Helsinki requirement).

Example:

Participants will be paid < $X > for their participation in the research. Reasonable travel expenses for any visits additional to normal care will be reimbursed.

15.6. ReportingThe CI shall submit an Annual Progress Report to OxTREC on the anniversary of the date of approval of the study. In addition, the CI shall submit an End of Study Report to OxTREC within 12 months of completion of the study.

15.7. Other Ethical ConsiderationsInclude any other general and study-specific ethical considerations, e.g. use of a placebo, involvement of vulnerable participants.

16. FINANCE AND INSURANCE

16.1. FundingDescribe financing arrangements.

16.2. InsuranceDescribe insurance arrangements

For University of Oxford sponsored studies:


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The University has a specialist insurance policy in place which would operate in the event of any participant suffering harm as a result of their involvement in the research (Newline Underwriting Management Ltd, at Lloyd’s of London).

17. PUBLICATION POLICYThe publication policy should cover authorship, acknowledgements, and review procedures for scientific publications. If there is a department or institution policy, or agreement, the protocol can refer to it. If the study results form part of a Masters or DPhil dissertation, please refer to Departmental policy on publications.

Consider describing how study results may be disseminated to study participants.


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18. REFERENCESInsert references used in text (preferably numbered, or in alphabetical order of first author).


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19. APPENDIX A: STUDY FLOW CHARTOptional


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20. APPENDIX B: SCHEDULE OF STUDY PROCEDURESOptional - Alter as required, delete if not wanted

Procedures Visits (insert visit numbers as appropriate)

Visit timinge.g. Day 0 e.g. Day 7

Screening Baseline

Informed consent

Demographics

Medical history

Physical examination

ECG

Eligibility assessment

Randomisation

Assessment 1 (describe)e.g. MRI

Assessment 2 (describe)



Questionnaires/behavioural tasks

Adverse event assessments


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21. APPENDIX C: AMENDMENT HISTORY

Amendment No.

Protocol Version No.

Date issued

Author(s) of changes Details of Changes made

List details of all protocol amendments here whenever a new version of the protocol is produced. This is not necessary prior to initial Ethics Committee submission.


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synopsis - admin.ox.ac.uk web viewsop. standard operating procedure. ... example: participants will...

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