Standard Operating Procedures for the Conduct of Clinical ...

1 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 *Templates are optional tools that can be used or revised per departmental Procedures . 2 TABLE OF CONTENTS LIST OF ABBREVIATIONS .. 4 LIST OF TEMPLATES .. 5 I. 100 GA GENERAL 8 101 Assuming and Fulfilling Responsibility for Good Clinical 9 102 SOP Development and Process .. 15 103 Ensuring Qualification of Site Personnel and research 18 104 23 105 Records Management, Accountability and 25 II.

2 200 RA REGULATORY 30 201 Essential 31 202 Initial and Ongoing 34 203 Reporting 37 III. 300 PM PROJECT 40 301 Protocol 41 302 Assessing Study 44 303 Study 49 304 Investigational Product 54 305 Source 58 306 Monitoring 61 307 Study 66 308 Protocol 69 IV. 400 SM SUBJECT 72 401 Subject Recruitment and 73 402 Informed 78 403 Eligibility and 83 Community Health Network Office of research Administration SOPs for the Conduct of Clinical research *Templates are optional tools that can be used or revised per departmental Procedures . 3 404 Subject Visits and 86 405 AE 91 V. 500 DM DATA 95 501 Clinical Data 96 VI. 600 QA QUALITY 100 601 Quality Assurance 101 602 Inspections by Regulatory 104 VII.

3 108 VIII. 200 Community Health Network Office of research Administration SOPs for the Conduct of Clinical research *Templates are optional tools that can be used or revised per departmental Procedures . 4 LIST OF ABBREVIATIONS AE Adverse Event (same as Adverse Drug Experience, Adverse Experience, Adverse Drug Reaction, Adverse Reaction) CHNw Community Health Network, Inc. CRC Clinical research Coordinator CRF Case Report Form CRO Contract research Organization DMC Data Monitoring Committee FDA Food and Drug Administration GCP Good Clinical Practice HIPAA Health Insurance Portability and Accountability Act of 1996 IB Investigator's Brochure IBC Institutional Biosafety Committee ICF Informed Consent Form ICH International Conference on Harmonization IND Investigational New Drug IRB Institutional Review Board NIH National Institutes of Health OHRP Office for Human research Protections ORA Office of research Administration PI Principal Investigator QA Quality Assurance SAE Serious Adverse Event SOP Standard Operating Procedure Community Health Network Office of research Administration SOPs for the Conduct of Clinical research

4 *Templates are optional tools that can be used or revised per departmental Procedures . 5 LIST OF TEMPLATES SOP # SECTION/TITLE TEMPLATE # TEMPLATE TITLE GA 100 GENERAL ADMINISTRATION GA 101 Assuming and Fulfilling Responsibility for Good Clinical Practice GA 101-A Delegation of Authority <<Protocol>> Template GA 101-B Form FDA 1572 GA 101-C Study Training Form Template GA 102 Document Development and Change Control GA 102-A Document Training Compliance Record Template GA 102-B SOP Template GA 102-C SOP Review GA 103 Ensuring Qualified Site Personnel and research Staff GA 103-A Orientation Template GA 104 Contracts GA 104-A Contract Routing Form GA 105 Records Management, Accountability, and Retention GA 105-A Request for Medical Records GA 105-B Offsite Storage Log Template RA 200 REGULATORY AFFAIRS RA 201 Essential Documents RA 201-A Regulatory and Study File Content Template RA 201-B Table of ICH Essential Documents RA 202 Initial and Ongoing Submissions RA 202-A Submission and Reporting Requirements RA 203 Reporting Requirements RA 203-A Reportable AE Decision Algorithm PM 300 PROJECT MANAGEMENT PM 301 Protocol Development PM 301-A Protocol Template PM 301-B Chart Review Protocol Template PM 302 Assessing Study Feasibility PM 302-A Study Review and Assessment Template PM 302-B Study Effort and Cost Considerations Template Community Health Network Office of research Administration SOPs for the

5 Conduct of Clinical research *Templates are optional tools that can be used or revised per departmental Procedures . 6 SOP # SECTION/TITLE TEMPLATE # TEMPLATE TITLE PM 302-C Salary Worksheet Template PM 302-D Per Subject Cost Worksheet Template PM 302-E Study Budget Worksheet Template PM 302-F Pre-Study Qualification Visit Agenda Template PM 302-G Pre-Study Qualification Visit Preparation Template PM 303 Study Start-Up PM 303-A Site Initiation Visit Preparation Template PM 303-B Site Initiation Visit Agenda Template PM 303-C Site Initiation Visit Management Template PM 303-D Site Responsibility Log Template PM 304 Investigational Product Management PM 304-A Investigational Product Receipt Form Template PM 304-B Subject Inventory Control Form Template PM 304-C Investigational Product Accountability Form Template PM 304-D Temperature Log Template PM 305

6 Source Documentation PM 305-A Source Documentation Template PM 306 Monitoring Visits PM 306-A Monitoring Visit Preparation Template PM 307 Study Completion PM 307-A End-of-Study Documentation Template PM 308 Protocol Compliance PM 308-A Protocol Deviation Log Template SM 400 SUBJECT MANAGEMENT SM 401 Recruitment SM 401-A Guideline for Recruitment and Advertising Practices SM 401-B Model Screening Script Template SM 401-C Recruitment Action Plan Template SM 402 Informed Consent SM 402-A Informed Consent Process SM 403 Eligibility and Enrollment SM 403-A Subject Eligibility Template SM 403-B Screening and Enrollment Log Template Community Health Network Office of research Administration SOPs for the Conduct of Clinical research *Templates are optional tools that can be used or revised per departmental Procedures .

7 7 SOP # SECTION/TITLE TEMPLATE # TEMPLATE TITLE SM 404 Subject Visits and Assessments SM 404-A Study Encounter Worksheet and Record Screening Template SM 404-B Study Encounter Worksheet and Record - Visit # Template SM 404-C Study Encounter Record - Physical Exam - Visit # Template SM 404-D Medical History Screening Template SM 404-E Adverse Event Log Template SM 404-F Concomitant Medication Log Template SM 405 AE Management SM 405-A Criteria for Recognizing and Managing AEs DM 500 DATA MANAGEMENT DM 501 Clinical Data Management NA QA 600 QUALITY ASSURANCE QA 601 Quality Assurance Audits QA 601-A Clinical Study Site Audit Template QA 602 Inspections by Regulatory Authorities QA 602-A Prepare for an FDA Inspection Template QA 602-B Procedures during an FDA Inspection Template Community Health Network Office of research Administration SOPs for the Conduct of Clinical research *Templates are optional tools that can be used or revised per departmental Procedures .

8 8 I. GA 100 GENERAL ADMINISTRATION 101 Assuming and Fulfilling Responsibility for Good Clinical Practice 102 SOP Development and Process 103 Ensuring Qualified Site Personnel and research Staff 104 Contracts 105 Records Management, Accountability, and Retention Community Health Network Office of research Administration SOPs for the Conduct of Clinical research *Templates are optional tools that can be used or revised per departmental Procedures . 9 SOP: GA 101 Assuming and Fulfilling Responsibility for GCP Version No.: Effective Date: May 1, 2017 supersedes Document: N/A 1. Procedure Principal Investigator assumes the responsibility for the Conduct of Clinical research and shall, therefore, personally oversee the Conduct of each Clinical study; ensuring that the research is conducted according to GCP, complies with applicable regulations, guidelines and institutional policy for conducting human subject research and use of investigational products.

9 These responsibilities include: Conducting research according to - the signed investigator statement, - the study plan/protocol, - applicable regulations Ensuring that no changes to the study plan/protocol are made unless - a request to make a change in the research is submitted to the sponsor and IRB and that the approval for the change is approved by the sponsor and IRB, or, - if a change is necessary to protect the safety, rights, or welfare of subjects, to notify the IRB and the sponsor within the time specified by the protocol, applicable regulations, institutional policy, and/or conditions of IRB approval Ensuring that the research is overseen by an IRB that complies with applicable regulatory requirement(s) and that the information and materials required for such oversight shall be provided as follows: - The initial and continuing review and approval of the proposed Clinical study: the protocol and related material are submitted to the IRB as required by applicable regulation, the protocol, and the IRB; study Procedures are not initiated until receipt of documentation of IRB approval; contingencies for IRB approval and continuing approval are met.

10 - Promptly reporting to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others. - Not making any changes in the research , except where necessary to eliminate apparent immediate hazards to human subjects, without IRB approval. Ensuring the process for obtaining and documenting the informed consent process is conducted according to 45 CFR 46. Ensuring the completion and submission of reports as required by the protocol, regulations, the IRB and sponsor or funding agency. Community Health Network Office of research Administration SOPs for the Conduct of Clinical research *Templates are optional tools that can be used or revised per departmental Procedures . 10 Specifically reporting: - AEs that occur in the course of the investigation(s) or as specified after the investigation is complete; - changes in the research activity; - all unanticipated problems involving risks to human subjects or others are reported as required by regulation and IRB requirements.