Standard Operating Procedures Version 7.1 : Content

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Introduction

1

Glossary of Abbreviations and Terms Used in the SOP

3

Chapter 1

The Standard Operating Procedures

 

1.1

Preparation of the Standard Operating Procedures (SOP)

12

1.2

Approval and Implementation of the SOP

15

Chapter 2

The Human Research Protection Unit

 

2.1

Overview and Structure of Siriraj Human Research Protection Unit

18

2.2

Ethical and Regulatory Mandates for Human Research Protection

27

2.3

Authority, Goal and Objectives of Human Research Protection Unit

30

2.4

Research Activities Covered by the Human Research Protection Unit

34

Chapter 3

The Institutional Review Board (IRB)

 

3.1

Authority, Role and Responsibilities of IRB

38

3.2

IRB Composition, Membership Policies and Expert Consultants

43

3.3

Conflict of Interest Disclosure and Confidentiality Agreement

48

3.4

Evaluation of the IRB Committee, Staff and IRB Activities

53

3.5

Relationships and Communication between Siriraj IRB and Others

57

3.6

IRB Required Investigator’s Actions

60

Chapter 4

Initial Review Process

 

4.1

Application for IRB Review

65

4.2

Submission, Preliminary Review and Primary Reviewer Assignment

68

4.3

Levels of IRB Initial Protocol Review and Determinations

71

4.4

Exempt Research Review

74

4.5

Expedited Review of Research Protocol

77

4.6

Full Board Initial Review of Research Protocol

81

Chapter 5

Considerations for IRB Approval of Research

 

5.1

Approval Criteria for Initial Review

85

5.2

Identification and Recruitment of Research Participants

90

5.3

Informed Consent: Requirements, Documentation and Waiving

95

5.4

Review for Research Involving Vulnerable Populations

102

5.5

Review for Research Requiring Additional Considerations

111

5.6

IRB Determination for Initial Review: Categories and Actions

122

Chapter 6

Continuing Review Process

 

6.1

Continuing Review of Active Protocol and Renewal

126

6.2

Review of Protocol Amendments

130

6.3

Handling and Monitoring of Safety Report

133

6.4

Reporting and Handling of Non-Compliance and Protocol Violation

139

6.5

Reporting and Handling of Complaints, Concerns and Comments

143

6.6

Study Closure and Final Report

148

6.7

Suspension or Termination of IRB Approval

151

Chapter 7

Convened IRB Meetings

 

7.1

IRB Meeting Scheduling and Notification

156

7.2

IRB Meeting Preparation and Conduct

158

7.3

Minutes of an IRB Meeting

163

Chapter 8

Documentation and Archiving

 

8.1

Documentation and Document Management

167

8.2

Electronic Data Security and Confidentiality Management

170

Chapter 9

Education/Training in Human Research Ethics

 

9.1

Education Requirement in Human Research Protection

172

9.2

Education and Training for Human Research Protection

175

Chapter 10

Quality Assessment and Quality Improvement

 

10.1

Quality Assurance and Quality Improvement Program

178

10.2

Site Visit and Compliance Monitoring

181