Regulatory Management: Critical Documents, Processes, and Reporting

Eva S. Zimmerman Clinical Research Coordinator

34th Annual Emergencies in Medicine Conference – Park City, Utah7 March 2016

Presentation Overview Introduction Critical Documents, Processes, and Reporting

Before the Clinical Phase of the Trial Commences During the Conduct of the Clinical Trial After Completion or Termination of the Trial

Q/A

Introduction Critical regulatory documents

serve to demonstrate compliance with: GCP Standards Sponsor FDA NIH Regulatory Authorities (IRB/IEC)

Collectively allow for evaluation of: Conduct of a clinical trial Quality of data produced

“In the interview, they told me the job would involve some paperwork…”

Before the Clinical Phase of the Trial Commences Investigator Brochure Signed Protocol and Amendments (If Any) Sample Case Report Forms Information Given to Trial Subject

Informed Consent Forms (Including all Applicable Translations) Advertisement for Subject Recruitment Any Other Written Information

Before the Clinical Phase of the Trial Commences, Cont.

Financial Disclosure Forms and Signed Financial Agreements Insurance Statements Signed Agreement(s) Between Involved Parties

Investigator/Institution and Sponsor Investigator/Institution and CRO Sponsor and CRO Investigator/Institution and Authority(ies) (If Applicable)

Can we start yet???

Before the Clinical Phase of the Trial Commences, Still Cont. Dated, Documented Approval of IRB/IEC of the Following:

Protocol + Amendments (If Applicable) CRF Informed Consent Form(s) Any Written Information to be Provided to the Subject(s) Advertisement for Subject Recruitment (If Applicable) Subject Compensation (If Any) Any Other Documents that Require Approval

Institution Review Board/Independent Ethics Committee Composition Regulatory Authority(ies) Authorization/Approval/Notification of Protocol (Where

Required)

Before the Clinical Phase of the Trial Commences, Almost There

CVs and Licensure for All Study Personnel Certification, Accreditation, or Other Validation of Lab/Facility to Perform

Tests/Procedures Lab Normal Values/Ranges for Tests/Procedures Included in the Protocol Instructions for Handling Investigational Products and Trial-Related Material Decoding Procedures for Blinded Trials Master Randomization List Instructions for SAE Reporting Pre-Trial and Site-Initiation Monitoring Reports

“Let’s get started!”

During the Clinical Conduct of the Trial All Updates to the Investigator’s Brochure All Revisions to:

Protocol Case Report Form Informed Consent Form Any Written Information Provided to Subjects Advertisement for Subject Recruitment (If Used)

Documentation of IRB/IEC Approval

During the Clinical Conduct of the Trial, Cont.

CVs and Licensure for All New Site Personnel Updates to Lab Normal Values/Ranges and Procedures/Tests Included in the

Protocol Documentation of IMP, Sample, and Trial-Related Material Shipment(s) Monitoring Visit Reports Correspondence Signed Informed Consent Forms Source Documents

During the Clinical Conduct of the Trial, Still Cont. Completed Case Report Forms + Documentation of Correction(s) Documentation of Serious Adverse Events + Safety Information Reporting All Site Logs/Records:

Subject Screening/Enrollment Logs Subject Identification Code List Investigation Medicinal Product Accountability Log Record of Retained Body Fluids/Tissue Samples (If Any)

…More updates

After Completion or Termination of the Trial

IND Safety Reports Investigator Site File/Regulatory Documentation:

Site Logs (Screening, Enrollment, Training, Equipment, Temperature, Etc.) Investigational Medicinal Product and Equipment/Supplies

Reconciled Drug Accountability Log Shipping Records/Receipts Documentation of returned (or destroyed) IMP or study equipment/supplies

Completed Subject Identification Code List Audit Certificate (If Applicable) Final Trial Close-Out Monitoring Report Treatment Allocation and Decoding Information Invoices

After Completion or Termination of the Trial, Cont. IRB

Notify your IRB of site closure Ensure important communication/reports are filed

Submissions Notifications Acknowledgements Approvals IRB Membership Lists Etc.

Archiving Clinical Study Report

~In Conclusion~

References “Essential Documents for the Conduct of a Clinical Trial.”

http://www.irb.umn.edu/download/2-13-2007.pdf. 26 Feb. 2016. “Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance.”

Apr. 1996. Web. 26 Feb. 2016. http://www.jli.edu.in/blog/2011/06/roles-and- responsibilities-of-clinical-resea

rch-coordinator-crc/. 26 Feb. 2016.

https://ccts.osu.edu/education-and-training-programs/research-education-and-training-programs/clinical-research-coordinator-resources/regulatory-documents. 26 Feb. 2016.

Regulatory Management: Critical Documents, Processes, and Reporting: Questions/Answers

Eva S. Zimmerman Clinical Research Coordinator

Eva.zimmerman@bcm.edu | https://www.linkedin.com/in/zimmermanevas