Standard Operating Procedures for the Conduct of Clinical ...

Office of Research Administration

Standard Operating Procedures for the Conduct of Clinical Research

SOP Manual for Compliance with International Conference on Harmonization (ICH) Good Clinical Practice Guidelines and

FDA Regulations at the Investigative Site

Community Health Network Office of Research Administration SOPs for the Conduct of Clinical Research

TABLE OF CONTENTS

LIST OF ABBREVIATIONS ........................................................................................... 4 LIST OF TEMPLATES ................................................................................................ 5

I.

100 GA GENERAL ADMINISTRATION.................................................... 8

101 Assuming and Fulfilling Responsibility for

Good Clinical Practice.................................................................. 9

102 SOP Development and Process .............................................. 15

103 Ensuring Qualification of Site Personnel and Research Staff...... 18

104 Contracts.................................................................................... 23

105 Records Management, Accountability and Retention.................. 25

II. 200 RA REGULATORY AFFAIRS........................................................... 30 201 Essential Documents................................................................... 31 202 Initial and Ongoing Submissions................................................. 34 203 Reporting Requirements.............................................................. 37

III. 300 PM PROJECT MANAGEMENT......................................................... 40 301 Protocol Development.................................................................. 41 302 Assessing Study Feasibility.......................................................... 44 303 Study StartUp............................................................................... 49 304 Investigational Product Management........................................... 54 305 Source Documentation................................................................. 58 306 Monitoring Visits........................................................................... 61 307 Study Completion......................................................................... 66 308 Protocol Compliance.................................................................... 69

IV. 400 SM SUBJECT MANAGEMENT.......................................................... 72 401 Subject Recruitment and Screening............................................. 73 402 Informed Consent......................................................................... 78 403 Eligibility and Enrollment.............................................................. 83

*Templates are optional tools that can be used or revised per departmental procedures.

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Community Health Network Office of Research Administration SOPs for the Conduct of Clinical Research

404 Subject Visits and Assessments.................................................. 86 405 AE Management.......................................................................... 91

V. 500 DM DATA MANAGEMENT................................................................ 95 501 Clinical Data Management........................................................... 96

VI. 600 QA QUALITY ASSURANCE............................................................. 100 601 Quality Assurance Audits............................................................ 101 602 Inspections by Regulatory Authorities......................................... 104

VII.

TEMPLATES.......................................................................................... 108

VIII.

GLOSSARY............................................................................................. 200

*Templates are optional tools that can be used or revised per departmental procedures.

3

Community Health Network Office of Research Administration SOPs for the Conduct of Clinical Research

LIST OF ABBREVIATIONS

AE CHNw CRC CRF CRO DMC FDA GCP HIPAA IB IBC ICF ICH IND IRB NIH OHRP ORA PI QA SAE SOP

Adverse Event (same as Adverse Drug Experience, Adverse Experience, Adverse Drug Reaction, Adverse Reaction) Community Health Network, Inc. Clinical Research Coordinator Case Report Form Contract Research Organization Data Monitoring Committee Food and Drug Administration Good Clinical Practice Health Insurance Portability and Accountability Act of 1996 Investigator's Brochure Institutional Biosafety Committee Informed Consent Form International Conference on Harmonization Investigational New Drug Institutional Review Board National Institutes of Health Office for Human Research Protections Office of Research Administration Principal Investigator Quality Assurance Serious Adverse Event Standard Operating Procedure

*Templates are optional tools that can be used or revised per departmental procedures.

4

Community Health Network Office of Research Administration SOPs for the Conduct of Clinical Research

LIST OF TEMPLATES

SOP # SECTION/TITLE

TEMPLATE # TEMPLATE TITLE

GA 100 GENERAL ADMINISTRATION

GA 101

GA 101-A Assuming and Fulfilling Responsibility for Good Clinical GA 101-B Practice

GA 101-C

Document Development and GA 102 Change Control

GA 102-A GA 102-B

GA 102-C

GA 103

Ensuring Qualified Site Personnel and Research Staff

GA 103-A

GA 104 Contracts

GA 104-A

GA 105

Records Management, Accountability, and Retention

GA 105-A GA 105-B

Delegation of Authority Template Form FDA 1572 Study Training Form Template Document Training Compliance Record Template SOP Template SOP Review Orientation Template Contract Routing Form Request for Medical Records Offsite Storage Log Template

RA 200 REGULATORY AFFAIRS

RA 201 Essential Documents

RA 202

Initial and Ongoing Submissions

RA 201-A RA 201-B RA 202-A

Regulatory and Study File Content Template Table of ICH Essential Documents Submission and Reporting Requirements

RA 203 Reporting Requirements

RA 203-A

Reportable AE Decision Algorithm

PM 300 PROJECT MANAGEMENT

PM 301 Protocol Development PM 302 Assessing Study Feasibility

PM 301-A

PM 301-B PM 302-A PM 302-B

Protocol Template

Chart Review Protocol Template Study Review and Assessment Template Study Effort and Cost Considerations Template

*Templates are optional tools that can be used or revised per departmental procedures.

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