c ta - standard operating procedures

SOP for Clinical Trial Application

RK/RAC/203/14/09/2009 Project Management Assignment Toronto Institute of Pharmaceutical Technology Version 1

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Standard Operating Procedures

Clinical Trial Application (CTA)

Project Management Assignment

RAC – 203

INSTRUCTOR

Prof. Ramjeet

Prepared by

Rajeev Kashyap



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Project Charter SOP of Clinical Trials Application

Version # RK/RAC-203-1 Revision Date 05September 2009

Approval of the Project Charter indicates an understanding of the

purpose and content described in this deliverable. By signing this

deliverable, each individual agrees.

APPROVER NAME SIGNATURE TITLE DATE

Mission: Adherence to GMP/GLP following ICH guidelines in manufacturing and safety of

drugs.

Vision: Target delivery system of quality drugs within affordable costs.



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PROJECT CHARTER Project Title Standard Operating Procedure for CTA

Project Start Date September 14,2009

Project Finish Date October 30,2009

Budget Information $ 72,520.00 (Approved)

Project Manager Mary Palmer

Project objective Develop a standard operating procedure for Clinical Trial Application

Approach *Communicate with all departments *Work closely with QC department *Collect all documents necessary for CTA *Monitor document; are complete and accurate

Roles and Responsibilities

Name and Signature

Role Position Contact Information

Kathleen Thompson,

(signed)

Project champion

Vice President

416 241 AZYX

Mary Palmer (signed)

Project Sponsor

Director 416 221 WVUT

Laura Butler (signed)

Project Manager

416 422 SRQP

Laura Butler (signed)

Steering committee member 416 532 ONML

Colleen James (signed)

Team Leader 416 443 KJIH

Karen Kellner (signed)

Supplier management 416 324 GFED

Approval of the Project Charter indicates an understanding of the purpose and content described in this deliverable. By signing this deliverable, each individual agrees to it.



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CONTENTS OF SOP FOR CLINICAL TRIAL APPLICATION

Section 1

1 . 1 Project Statement

1. 2 Project Description

1 . 3 Project Goals and Objective

1 . 4 Project Scope

1 . 5 Critical Success Factors

1 . 6 Assumptions

1 . 7 Constraints.

Section 2 Project Authority and Milestones 2 .1 Project Funding Authority

2 .2 Project Oversight Authority

2 .3 Major Project mile stones

Section 3 Project Organization

3.1 Project Structure

3.2 Roles and Responsibilities

3. 3 Project Facilities & Resources

Section 4

4.1 Point of Contact

Section 5

Glossary

Section 6

Revision History

Section 7

Appendices



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Section 1. Project Overview

1.1 Problem Statement

It is designed to provide tools and relevant links in order to facilitate the successful filing of a

Clinical Trial Application (CTA) to Health Canada.

1.2 Project Description

This SOP will be a tool for filling of Clinical Trial Application for Health Canada avoiding any

discrepancies in understanding of documents and requirements of Health Canada

1.3 Project Goals and Objectives

It is designed to provide tools and relevant links in order t o facilitate the successful filing of a

Clinical Trial Application (CTA) to Health Canada. It is based on Health Canada’s Guidance for

Clinical Trials.

The information provided within this package is for clinical trials that involve the use of

Pharmaceutical and/or Biological and Radiopharmaceutical drugs in human subjects.

The information does not apply to clinical trials involving Medical Devices and Natural Health

Products.

SCOPE DEFINITION: Input, Tools and Technique, and Outputs

INPUTS

Organizational process assets

Project Charter

Project Scope Statement

Project Scope management Plan

Approved change requests

TOOLS & TECHNIQUES

Product analysis

Alternatives identification

Expert judgements

Stakeholders judgements

OUTPUTS

Project Scope Statement

Requested Changes

Project Scope management plan(updates)



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1.4 Project Scope

The information provided within this package is for clinical trials that involve the use of

Pharmaceutical and/or Biological and Radiopharmaceutical drugs in human subjects.

The information does not apply to clinical trials involving Medical Devices and Natural Health

Products.

Project Includes

Project Excludes

PROJECT ORGANIZATION

The project sponsor will make all major decisions in consultation with project

champion and steering committee member. Project Manager is responsible for

the successful completion of the project. Team leaders and Supplier project

managers report to the Project Manager

Project Sponsor

Mary Palmer

Steering committee

Laura Butler

Project Manager

Brian Bretz

Team Leaders

Colleen James

Supplier Management

Karen Kellner

Project Champion

Kathleen Thompson,



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RELATIONSHIP BETWEEN STAKEHOLDERS AND THE PROJECT

Duties and Responsibilities

PROJECT ORGANIZATION: DUTIES AND RESPONSIBILITIES

Project Sponsor Mary Palmer

Final decision making authority. Consults Project champion and steering committee

Project Champion Kathleen Thompson,

Advise project sponsor

Steering committee Laura Butler

Advise project sponsor

Project Manager

Brian Bretz

Responsible for the success of the project

Team Leaders Colleen James

Report to project Manager

Supplier Management Karen Kellner

Report to project Manager

PROJECT STAKEHOLDERS

PROJECT TEAM

PROJECT MANAGEMENT

TEAM

PROJECT SPONSOR

&

PROJECT MANAGER



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STAKEHOLDER ANALYSIS

Stakeholder analysis provides information about key stakeholders to help manage relationships

with them

External Stakeholders

Health Canada

Reviews clinical trial protocols to assess the protection and safety of the participants

Assesses the quality of the drugs

assures review by Research Ethics Boards

verifies the qualifications of Principal Investigators and monitors and reviews

Adverse Drug Reactions (ADRs).

Sponsor

In compliance with the Canadian Food and Drug Regulations, Division 5

Adheres to good clinical practices for the proper use of the drugs,

Record keeping

Reporting of Considers ethical issues

Protocol Adverse Drug Reactions (ADRs).

Research Ethics Board

The informed consent documents

Conflicts of interest

Financial agreements.

Internal Stakeholders

Project Sponso

Project Champion

Steering committee members

Project Manager

RA Manager

Team Leaders

Project management Lead

Supplier Management



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Stakeholder’s Flow chart

Standard Operating Procedures


A CTA contains information and documentation to support the objectives and goals of the

proposed clinical trial. It also includes data to support the drug product quality. The clinical and

quality components of the application are reviewed in parallel and both must be satisfactory

before a No Objection Letter can be issued.

Sponsors must file a Clinical Trial Application (CTA) to conduct clinical trials in Phases I through

III of drug development and comparative bioavailability trials.

This includes applications to conduct clinical trials involving marketed products where the

proposed use of the product is outside the parameters of the authorized

SOP is an authorized written procedure giving instructions for performing operations not

necessarily specific to a given product or material (e.g. equipment operation, maintenance and

cleaning; validation; cleaning of premises and environmental control; sampling and inspection).

Stakeholders

Internal

Project Sponsor

Mary Palmer

Supplier Management

Karen Kellner

Steering committee

Laura Butler

Project Champion

Kathleen Thompson,

Project Manager

Brian Bretz

RA

Sonia Barragan

Project Management

Jeanne Heschele

Team Leaders

Colleen James

External

Health Canada

Kathleen Thompson,

Suppliers

Tiffany Binderup Group

REB

Mila Dacorro



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Certain SOPs may be used to supplement product-specific master and batch production

documentation

SCOPE

Project Justification

It is a mandatory requirement of Health Canada that Sponsor must file a Clinical Trial

Application (CTA) to conduct clinical trials in Phases I through III of drug development and

comparative bioavailability trials. The first step for the successfully filing of a CTA is a well-

documented procedure that ensures that everyone involved is well aware of the documentation

methods.

EFFICASY

QUALITY

SAFETY



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1.5 Critical Success Factors

The Food and Drugs Act and Regulations provide authority to Health Canada to regulate the

sale of drugs for the purposes of use in human clinical trials. Part C, Division 5 of the

Regulations defines specific Clinical Trial Application (CTA) and Clinical Trial Application

Amendment (CTA-A) requirements for the sale and importation of drugs for use in human

clinical trials in Canada.

Division 5 of the Regulations came into force since September 2001 and was developed to

recognize the generally accepted principles of good clinical practice

The Regulations are consistent with the principles, definitions and standards found in the

Health Canada / ICH Guidance Documents E6: Good Clinical Practice: Consolidated

Guideline,

E8: General Considerations for Clinical Trials and

E2A: Clinical Safety Data Management:

Definitions and Standards for Expedited Reporting.

This guidance documents, developed through the International Conference on Harmonisation

(ICH) process have been adopted by Health Canada. Together, they define parameters for the

Design

Conduct

Performance

SCOPE PLANNING

SCOPE

DEFINITION

SCOPE VERIFICATION

SCOPE CONTROL

CREATE WBS



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Monitoring

Auditing,

Recording, analysis

Reporting of clinical trials.


A must to file Clinical Trial Application (CTA) to conduct clinical trials in Phases I through III of

Drug development and

Comparative bioavailability trials. This includes applications to conduct clinical trials

involving marketed products where the proposed use of the product is outside the

parameters of the authorized drugs.

A similar Health Canada review and approval process exists for clinical trials involving

natural health products. Under the Natural Health Products Regulations, which came

into effect on January 1, 2004.

Natural health products (NHPs) are defined as:

* Vitamins and minerals

* Herbal remedies

* Homeopathic medicines

* Traditional medicines such as traditional Chinese medicines

* Probiotics, and

* Other products like amino acids and essential fatty acids.

Submissions satisfying the NHP Directorate's requirements will be issued a Notice of

Authorization to commence the trial.

1.6 Assumptions

Sponsors conducting clinical trials in Canada with products that have received a Notice of

Compliance with Conditions (NOC/c) are also required to file a CTA.

the product is outside the parameters of the authorized Notice of Compliance (NOC) or Drug

Identification Number (DIN) application .



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1.7 Constraints

Project constraints being imposed in areas such as schedule, budget, resources, products to

be reused, technology to be employed, products to be acquired, and project constraints based

on the current knowledge today interfaces to other products.

IMPORTANT: Each Module should be submitted in a separate binder.

The modules are organized and numbered consistently in an internationally adopted format -

the Common Technical Document (CTD). Adhering to the CTD format facilitates evaluation by

Health Canada and ensures consistency of documents in subsequent stages of the drug

authorization process. Additional information about the CTD format is available on the web site

of the International Conference on Harmonisation (ICH) at www.ich.org.

The CTA should be sent directly to the appropriate Directorate. The outer label should be clearly

state "Clinical Trial Application".

DOCUMENT NOT INCLUDED IN THESE MODULES SHOULD NOT BE FILED AND IT IS

OUT OF PROJECT SCOPE.

3.3 Project success:

Studies conducted by the sponsor have stated that the project will be a success if it can be

completed within 50 days.

3.4 Deliverables;

Team Contract

Project management plan

Scope statement

Work breakdown Structure

Standard operating Procedure

http://www.ich.org/



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Clinical Trial Application (CTA) The CTA is composed of three parts (modules):

Outline of a CTA / CTA-A

Module Pharmaceuticals Biologicals and Radiopharmaceuticals

1 Administrative / Clinical Information

1.1

Table of Contents (Modules 1-3)

1.2 Application Information

1.2.1 Drug Submission Application Form (HC/SC 3011)

1.2.2 Information on Prior-related Applications

1.2.3* Investigator’s Brochure

1.2.4* Protocol Synopsis (PSEAT-CTA) Submission Rationale /

Brief Summary of the Drug Product

1.2.5* Study Protocol(s)

1.2.6 Informed Consent Document(s)

1.2.7 Clinical Trial Site Information

1.2.8 Canadian Research Ethics Board(s) Refusals

1.2.9 Foreign Refusals

1.2.10 Letters of Access

1.2.11 Other Application-related Information

1.3 Electronic Review Documents

2 Common Technical Document Summaries



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2.1 Common Technical Document Table of Contents

2.3 ..............

2.3⁷* Quality Overall Summary

3 Quality

3.1 Table of Contents of Module 3

3.2 Body of Data

3.2.R.1

Production Documentation

3.2.R.2

Executed Batch Records

3.3 Literature References

* These items should be submitted in hard copy and in electronic format accepted by Health Canada

( CD - ROM) TIME MANAGEMENT

The start date of the project is September 14, 2009 and the Finish date is October 30, 2009. The total

duration for this project is 35 days. A work breakdown structure at level 2 is given below. MS Project

software or any other validated program must be used for this task.

7.1 Gantt Chart Activity List: Level 2



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7.2 Gantt chart: Activity List Level 3 : Standard Operating Procedure for CTA



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The WBS at level 3 is given in the above Gantt Chart

Milestones

At completion of a specific set of documentation milestones are given to review project progress. There

are 10 milestones for this project. The following Gantt chart lists the dates of each milestone

MILESTONE LIST

Standard Operating Procedure for CTA

Milestone List

Activity Milestone Date

2.Study Correspondence 0d Mon 28/09/09 Mon 28/09/09 "6,10SS"RA

"Correspondence: letters, faxes, memos, emails" 0d Mon 05/10/09 Mon 05/10/09 21SS RA

"Correspondence: letters, faxes, memos, emails" 0d Fri 09/10/09 Fri 09/10/09 30SS RA




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"Correspondence: letters, faxes, memos, emails" 0d Tue 13/10/09 Tue 13/10/09 61SS RA

"Correspondence: letters, faxes, memos, emails" 0d Thu 15/10/09 Thu 15/10/09 88SS RA




"Correspondence: letters, faxes, memos, emails" 0d Wed 28/10/09 Wed 28/10/09 148SS RA

8.0 COST MANAGEMENT

Project cost management includes the process required to ensure that a project team completes a

project within in an approved budget.

TIME MANAGEMENT

The start date of the project is September 14, 2009 and the Finish date is October 30, 2009. The total

duration for this project is 35 days. A work breakdown structure at level 2 is given below. MS Project

software or any other validated program must be used for this task.

Gantt Chart Activity List: Level 2



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7.2 Gantt chart: Activity List Level 3 : Standard Operating Procedure for CTA



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The WBS at level 3 is given in the above Gantt Chart

7.3 Milestones

At completion of a specific set of documentation milestones are given to review project progress. There

are 10 milestones for this project. The following Gantt chart lists the dates of each milestone

MILESTONE LIST

Standard Operating Procedure for CTA



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7.4 Milestone List

Activity Milestone Date

2. Study Correspondence 0d Mon 28/09/09 Mon 28/09/09 "6,10SS"RA


"Correspondence: letters, faxes, memos, emails" 0d Fri 09/10/09 Fri 09/10/09 30SS RA







"Correspondence: letters, faxes, memos, emails" 0d Wed 28/10/09 Wed 28/10/09 148SS RA

WBS: Inputs, Tools & Techniques, Outputs

INPUTS

Organisational process assets

Project scope statement

Project Scope Management Plan

Approved Change requests

TOOLS & TECHNIQUES

Work Breakdown Structure Template

Decomposition

OUTPUTS

Project scope statement(updates)

WBS & WBS Dictonary

Scope Baseline

Project Scope management plan(updates) & requested Changes



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8.0 COST MANAGEMENT

Project cost management includes the process required toensure that a project team completes a

project within in an approved budget.

8.1 Project Cost

Project team normally prepares cost estimates at various stages of the project and this estimates are

fine tuned as time progress.

8.2 Bottom up Cost estimation

To increase the accuracy of cost estimation a bottom up cost estimation method is followed for this

project The current project cost is estimated to be $72,520. The cost WBS at level 2 is given in the

following Gantt chart using MS Project program.

Project Cost Management overview

COST ESTIMATING

•1. INPUT•Enterprise Enviornmental Factors

•Organisational Process Assets

•Project Scope Statement

•WBS & WBS Dictionary

•Project Management Plan : Schedule management plan, Staffing Management plan, Risk register.

•2. TOOLS & TECHNIQUES•Analogous estimating.

•Determine resourse cost rates

•Bottom-up estimating.

•Parameteric estimating

•Project management software.

•Vendor bid analysis

•Cost of quality.

•3. OUTPUTS•Activity cost estimates

•Activity cost estimate supporting details

•Requested changes.

•Cost management plan(updates)

COST BUDGETING

•1. INPUTS

•Project scope statement•WBS &WBS Dictonary

•activity cost estimates

•activity cost estimate supporting details

•Project schedule

•Resourse Calandars.

•Contracts

•Cost management plan

•2. TOOLS & TECHNIQUES•Cost aggregation

•Reserve analysis

•Parametric estimating.

•Funding limit reconcilition

•3. OUTPUTS•Cost Baseline

•Project funding requiements

•Cost management plan (updates)

•Request changes

COST CONTROL

•1. INPUTS•Cost baseline

•Project funding requirements

•Performance report

•Work Performence inforfation

•Approvd change request

•Project management plan

•2. TOOLS &TECHNIQUES•Cost change control system

•Performance measuements analysis

•Forecasting

•Project performancce reviews

•Project management software

•Variance measurements

•3. OUTPUTS•Cost estimate (updates)

•Performance Measures

•Cost baseline (updates)

•Forecasted completion

•Requested Changes

•Recomended corrective actions

•Organisational process assets

•Project management plan(updates)



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Project cost Estimation Gantt Chart

COST : WORK BREAKDOWN STRUCTURE

SOP FOR CTA Cost Analysis Level 2.mpp

8.4 COST BUDGETING

Project cost budgeting involves allocating the project cost estimate to various tasks

The Cost budgeting based on WBS level 3 is to be carried out using MS Project software or any other

validated system as given in the following Gantt. Chart.

Cost budgeting Gantt Chart



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8.1 Project Cost



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Project team normally prepares cost estimates at various stages of the project and this estimates are

fine tuned as time progress.

8.2 Bottom up Cost estimation

To increase the accuracy of cost estimation a bottom up cost estimation method is followed for this

project The current project cost is estimated to be $72,520. The cost WBS at level 2 is given in the

following Gantt chart using MS Project program.

8.3 Project cost Estimation Gantt Chart

COST : WORK BREAKDOWN STRUCTURE

SOP FOR CTA Cost Analysis Level 2.mpp

8.4 COST BUDGETING

Project cost budgeting involves allocating the project cost estimate to various tasks

The Cost budgeting based on WBS level 3 is to be carried out using MS Project software or any other

validated system as given in the following Gantt. Chart.

PROJECT QUALITY MANAGEMENT



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Project quality management ensures that the project satisfies the stated or implied

Level of quality and the key out puts of quality management includes:

1. Quality Management Plan

2. Quality matrices

3. Quality Check lists

9.1 Quality Management Plan

The main goal of the project is to develop a Standard Operating Procedure for a CTA within the targeted

time.

By scheduling a suite of Quality Assurance Reviews, to be undertaken by an independent

person to the project, the customer will be provided with a “trusted view” of the overall progress

of the project and the likelihood of the deliverables actually meeting the quality targets agreed.

All the procedures and procurements will be carried out as per established standards ie

GMP, GLP, ICH and ISO standards

9.2 Matrices and Reporting

A metric is a standard of measurement. Examples are customer satisfaction, failure

rates and availability of service and goods. The quality management team at the site is

responsible for actively identifying issues and trends to support continuous

improvement. This is facilitated through the collection of quality and compliance Key

Performance Indicators. The information collected could be from a variety of sources

such regulatory audits, self inspections, trending reports or non-conformance quality

systems monitoring programs.

The site quality team is responsible for providing visibility of the quality information

through appropriate forums, reports and communication channels. The quality and

compliance Key Performance Indicators are reviewed and reported to both the Project

management teams and Corporate Quality and Operations management on a

scheduled basis.



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9.3 Quality Check list

A list if items to be noted or consulted. It helps the project team to verify that a set of required steps has

been performed.

Whether reports are complete

Whether suppliers are qualified or ISO certified

Whether the reports are signed and dated.

9.4 Quality control measures

9.5 Control charts .control charts illustrates the progress of a task overtime

In this cost control chart mean amount is calculated from the total cost divided by number of days.

Lower and upper limits are fixed for daily cost control.



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9.6 Histograms

A histogram showing number of tasks completed on a daily basis

Histograms show a bar graph of distribution of variables

Cost Control Chart

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10

Days

Am

ou

nt

in $

Lower Limit

Mean

Upper Limit

Daily expense

Linear (Daily expense)



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10.0 Conclusion.

Project success is an intangible, realized through consensus, collaboration and communication. In this

SOP best project management standards and practices are used to increase the likelihood of overall

success. Throughout this project milestones are provided for the logical flow of project planning and

execution, providing for periodic review and ongoing reflection. It will provide potential benefits, as

defined checkpoints for management control and success of the project.

Standard operating procedures (SOPs) and records

Standard operating procedures and associated records of actions taken or, where

appropriate, conclusions reached should be available for:

(a) Equipment assembly and validation;

(b) Analytical apparatus and calibration;

(c) Maintenance, cleaning and sanitization;

0

2

4

6

8

10

12

14

16N

um

be

r o

f T

as

ks

1 2 3 4 5 6 7 8 9 10

Days

QC HISTOGRAM

HISTOGRAM



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(d) Personnel matters including qualification, training, clothing and hygiene;

(e) Environmental monitoring;

(f ) Pest control;

(g) Complaints;

(h) Recalls;

(i) Returns.

There should be standard operating procedures and records for the receipt of each

delivery of starting material and primary and printed packaging material.

The records of the receipts should include:

(a) The name of the material on the delivery note and the containers;

(b) The “in-house” name and/or code of the material if different from (a);

(c) The date of receipt;

(d) The supplier’s name and, if possible, manufacturer’s name;

(e) the manufacturer’s batch or reference number;

(f ) The total quantity, and number of containers received;

(g) The batch number assigned after receipt;

(h) Any relevant comment (e.g. state of the containers).

There should be standard operating procedures for the internal labelling, quarantine and

storage of starting materials, packaging materials and other materials, as appropriate.

Standard operating procedures should be available for each instrument and piece of

equipment (e.g. use, calibration, cleaning, maintenance) and placed in close proximity to

the equipment.

There should be standard operating procedures for sampling, which specify the

person(s) authorized to take samples.

The sampling instructions should include:

(a) The method of sampling and the sampling plan;

(b) The equipment to be used;

(c) Any precautions to be observed to avoid contamination of the material or

any Deterioration in its quality;

(d) The amount(s) of sample(s) to be taken;

(e) Instructions for any required subdivision of the sample;

(f ) The type of sample container(s) to be used, and whether they are for aseptic

sampling or for normal sampling, and labelling;



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(g) Any specific precautions to be observed, especially in regard to the sampling of

sterile or noxious material.

There should be a standard operating procedure describing the details of the batch (lot)

numbering system, with the objective of ensuring that each batch of intermediate, bulk or

finished product is identified with a specific batch number.

The standard operating procedures for batch numbering that are applied to the

processing stage and to the respective packaging stage should be related to each other.

The standard operating procedure for batch numbering should ensure that the same

batch numbers will not be used repeatedly; this applies also to reprocessing.

Batch-number allocation should be immediately recorded, e.g. in a logbook. The record

should include at least the date of allocation, product identity and size of batch.

There should be written procedures for testing materials and products at different stages

of manufacture, describing the methods and equipment to be used. The tests performed

should be recorded.

Analysis records should include at least the following data:

(a) The name of the material or product and, where applicable, dosage form;

(b) The batch number and, where appropriate, the manufacturer and/or supplier;

(c) References to the relevant specifications and testing procedures;

(d) Test results, including observations and calculations, and reference to any

specifications (limits);

(e) Date(s) and reference number(s) of testing;

(f ) The initials of the persons who performed the testing;

(g) The date and initials of the persons who verified the testing and the calculations,

where appropriate;

(h) A clear statement of release or rejection (or other status decision) and the dated

signature of the designated responsible person.

Written release and rejection procedures should be available for materials and products,

and in particular for the release for sale of the finished product by an authorized person.

Records should be maintained of the distribution of each batch of a product in order, e.g.

to facilitate the recall of the batch if necessary.

Records should be kept for major and critical equipment, as appropriate, of any

validations, calibrations, maintenance, cleaning, or repair operations, including dates

and the identity of the people who carried these operations out.



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The use of major and critical equipment and the areas where products have been

processed should be appropriately recorded in chronological order.

There should be written procedures assigning responsibility for cleaning and sanitation

and describing in sufficient detail the cleaning schedules, methods, equipment and

materials to be used and facilities and equipment to be cleaned. Such written

procedures should be followed.

References.

www.ich.org.

RAC 203 Resource Materials

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_pre_application-

eng.php

http://www.ich.org/

c ta - standard operating procedures

Health & Medicine

project authority

project goals

project structure

project overview

project statement

project descriptionthis

project scopethe information

supplier project managers