Handbook for Clinical Investigators

This text is for at clinical investigators, usually physicians, especially those conducting clinical trials to evaluate new drugs. It is the product of a respected clinical investigator sharing his experiences and insights, so that others can share in the excitement of clinical research while avoiding some of the pitfalls that inevitably beset the clinical trialist. The book provides practical advice on how to interact with various "monitors," auditors and project leaders running the trial. It also gives advice on how to recruit patients to the trials. The author looks at subjects such as allocation of time, space and staff. This book is predominantly aimed at doctors performing clinical trials for pharmaceutical companies and will be of great help to Heads of Clinical Research in pharmaceutical companies - also to academic staff in university clinical departments, particularly pharmacology.

Preface

ix

Motivation: What's in it for me?

1

(6)

How we got there: approach by a sponsor

2

(1)

How we got there: approach by the potential investigator

3

(1)

Mission-driven or curiosity-driven research

3

(1)

Rewards

4

(1)

Cash

4

(1)

Reputation and publication

5

(1)

The main task of the clinical investigator

5

(1)

The team approach

5

(2)

Brief overview of drug development

7

(4)

Pre-clinical

7

(3)

Clinical

10

(1)

Drug registration procedures

10

(1)

Regulators and the Good Clinical Practice guidelines

11

(14)

The Good Clinical Practice directives

11

(2)

Protection of the subject

11

(1)

Protection of the data

12

(1)

European vs. USA requirements

12

(1)

Ethical issues

13

(4)

Declaration of Helsinki

13

(1)

Investigator

14

(1)

Protocol design

14

(1)

Ethics committee

14

(2)

Temptations in an investigator's life

16

(1)

The duties of an investigator

17

(2)

The principal investigator

18

(1)

The clinical trial subject

19

(3)

The doctor-patient relationship is preserved

19

(1)

Informed consent

20

(2)

Standard operating procedures

22

(3)

The sponsor's SOPs

22

(1)

The contract research organisation's SOPs

22

(1)

Your own SOPs (you should have some!)

23

(1)

Compliance

23

(2)

The sponsor

25

(12)

The project team

25

(1)

The monitor

26

(1)

Source document verification

27

(1)

Audit

27

(1)

The contract

28

(4)

Financial details

28

(2)

What the sponsor will provide

30

(1)

What the investigator will provide

30

(1)

Confidentiality

31

(1)

The protocol

32

(2)

Structure

34

(3)

Introduction

34

(1)

Subject population

34

(1)

Description of test articles (i.e. drugs)

34

(1)

Procedures and methods

34

(1)

Statistical and analytical methods

35

(1)

Ethical and GCP issues

35

(1)

Administrative issues

35

(2)

Practical issues -- running the trial

37

(18)

Time

37

(1)

Space

38

(1)

Staffing

38

(2)

The study site coordinator

38

(2)

Communication

40

(2)

Face-to-face conversations

41

(1)

Telephone

41

(1)

Meetings

41

(1)

Facsimile transmission and electronic mail

41

(1)

Letters

42

(1)

Training

42

(2)

Documents

44

(6)

The investigator site file

44

(1)

The investigator's brochure

44

(1)

The curriculum vitae

45

(1)

The clinical files (patient notes)

45

(2)

The case report form

47

(1)

Error correction

48

(1)

Dealing with data queries

48

(2)

The drugs - storage and care

50

(1)

The randomisation code

50

(1)

Breaking the code

51

(1)

How to cope with problems or disasters

51

(4)

Adverse events (AEs)

51

(1)

Serious adverse events (SAEs)

52

(1)

Operational problems

53

(2)

Publication

55

(4)

By the investigator

55

(1)

By the sponsor

56

(1)

The investigator's duty to publish

57

(1)

The issue of authorship

58

(1)

Postscript

59

(2)

Glossary and list of abbreviations

61

(10)

Notes

71

(2)

Index

73

What is included with this book?

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.

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Handbook for Clinical Investigators

Summary

Table of Contents

Supplemental Materials