Acknowledgments

vii

Foreword

x

I

Introduction

1

II

Federal Regulations Governing the Obligations of Clinical Investigators of Regulated Articles

2

III

The Clinical Research Organization

3

A

Contract Research Organizations and Site Management Organizations

3

B

Good Clinical Practice Guidelines

5

C

Declaration of Helsinki

7

D

Sponsor of a Clinical Trial

7

IV

Investigator Responsibilities

8

A

Condensed Version

8

B

Clinical Trial Monitoring of Documentation

9

C

Investigator Responsibilities

10

V

Duties of the Clinical Research Coordinator

16

A

Compiling Prestudy Documents

17

B

Creating and Maintaining Study Files

19

C

Obtaining CLIA Laboratory Certification as it Pertains to Clinical Research

22

VI

The Creation of Study Source Documents

29

A

Source Documents—What are They?

29

B

Source Document Examples

30

C

Types of Medical Reports Generated While a Subject is Enrolled in a Study

30

D

Good Clinical Research Documentation Details

31

E

Source Documentation Suggestions

32

F

Meeting the Requirements of Source Documentation

35

G

Data Clarification and Adverse Event Reporting

35

H

Queries

41

I

Identifying Data Problems

43

VII

Obtaining Informed Consent and Assent Approval

46

A

Obtaining Informed Consent

46

B

Obtaining Institutional Review Board Approvals

50

C

Reviewing the Protocol and Obtaining Signatures

50

D

HIPAA Regulations and Clinical Research

51

E

Clinical Research; Study Assent in Adolescents/Children

52

VIII

Pertinent Forms and Study Records

54

A

The Test Article Inventory System

54

B

The Drug Accountability Record

54

C

Paper Case Report Forms

55

D

Authorized Representative Signature Record (Site Signature Log)

57

E

The Adverse Experience Form

57

F

Specimen Handling and Submission Forms

59

G

The Subject Enrollment Form

59

H

The Site Visit Log (Monitor Log)

59

I

The Telephone Log

59

J

Delegation of Authority Log

60

IX

The Prestudy Site Visit

61

A

Site Initiation Visit

61

X

Recruiting and Enrolling Subjects

63

A

Prospective Subject Groups

63

B

Methods of Publicizing the Study

63

C

Presenting the Study to the Subject

65

XI

Conducting the Study and Keeping Records

67

A

Study Activities

67

B

Subjects Lost to Follow-Up

68

C

Withdrawing a Subject

68

D

Site Visits during the Study

68

E

Closing the Study and Retaining Records

69

XII

Preparing for an FDA Audit

71

A

FDA Inspections of Clinical Trials

71

B

Types of FDA Inspections

72

C

Parts of the Investigation

73

D

Preparation and Instructions for an FDA Audit

74

E

Common FDA Inspection Findings

79

F

Common Problems Identified in Audits of Clinical Trials

81

XIII

Clinical Research: Potential Liability

83

A

Fraud

83

B

Negligence

85

C

Legal Liability and the Clinical Research Coordinator

86

XIV

Writing the Study Summary

87

A

Biostatistical Report

87

B

Integrated Clinical Study Report

87

C

Articles for Publication

87

XV

Achieving Credibility and Recognition as a Clinical Research Coordinator

88

A

Attending Investigator Meetings

90

B

How to Work with a Difficult Clinical Research Associate

91

XVI

Electronic Data Capture and Clinical Trials

93

XVII

Appendices

97

Appendix I

Helpful Sources

97

A

Names and Addresses of Clinical Research Resources

97

B

Important Fda Websites for Institutional Review Boards and Clinical Investigators

99

Appendix II

Forms Used during the Course of a Clinical Study

102

Form 1

Information Regarding Participation in a Clinical Trial

102

Form 2

The Statement of Investigator Form (FDA 1572)

105

Form 3

Bill of Rights for Study Subject Volunteer

109

Form 4

The Medwatch Adverse Experience Form

110

Form 5

Informed Consent Form

111

Form 6

The Administrative Checklist

113

Form 7

Initial Adverse Experience Report Sheet

115

Form 8

Source Sample Telephone Log

116

Form 9

Sample Study Advertisement Office Sign

117

Form 10

Sample Screen Visit Letter

118

Form 11

Sample Baseline Visit Letter

119

Form 12

Ongoing Study Visit Letter

120

Form 13

Sample Final Study Letter

121

Form 14

Sample Financial Disclosure Certification Form

122

Form 15

Sample Hipaa Authorization to Access Protected Health Information

124

Form 16

STOP: Before Any Med Changes

126

Form 17

STOP: this Patient is a Participant in a Research Project

127

Form 18

Transporting Study Material from Main Site to Satellite Sites

128

Form 19

Sample Principal Investigator Delegation of Responsibility Form

129

Form 20

Sample Curriculum View Form

130

Form 21

Patient Assent Form

131

Appendix III

Conversion Tables

133

A

Conversion to Military Time

133

B

Measures and Equivalents

134

C

Conversion Charts for Height and Weight Measurements

135

Appendix IV

Common Terms and Acronyms

136

Appendix V

Glossary of Terms

138

About the Author

157