The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial

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1 The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial Clinical Research Operations & Regulatory Support (CRORS) Ann Glasse, RN, BSN, MBA Director-CRORS

2 Objectives To understand: The definition and purpose of the Regulatory Binder/Trial Master File (TMF) The required essential documents Maintenance of the Regulatory Binder/Trial Master File 2

3 Definition International Conference On Harmonization- Good Clinical Practice (E-6) (ICH-GCP 8.1) Defines Essential Documents as: Documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. ICH-GCP E-6 website: 3

4 Purpose These documents serve to demonstrate: Compliance of the investigator, sponsor and monitor with the standards of GCP and with all applicable regulatory requirements. Management of a trial when documents are filed in timely manner. Documents are available for review by study monitors, auditors and regulatory authorities to demonstrate validity of study conduct and data integrity. **The regulatory binder/trial master file should be established at the beginning of the trial and maintained throughout. 4

5 IRB Essential Documents IRB initial submissions & approvals IRB submission form IRB approval letter IRB approved documents Study Protocol Version # and date Signed & dated IRB communications Amendments submissions & approvals Modification submission form Protocol Revisions Revision date and/or version number Signed & dated IRB approval letter Other IRB approved documents IRB communications 5

6 IRB Essential Documents Reportable New Information (RNI) [SAEs, Deviation/Violation, Exception, Unanticipated Problems, etc.] RNI submission form IRB approved documents, if applicable IRB acknowledgement letter IRB communications Continuing Report submissions & approvals IRB continuing review report AE logs and deviation logs IRB approval letter IRB approved documents IRB communications Final study report Final study report submission (all applicable logs/reports) IRB acknowledgment of study closure 6

7 IRB Essential Documents Informed Consent Forms (ICFs) UM-ICFs, JHS-ICFs, any translated versions and certificate of translation Initial approved version and all applicable revisions HIPAA Research Authorization Form B Translated versions Initial approved version and all applicable revisions Information provided to or seen by (potential) subjects Advertisement for subject recruitment, web postings Letters, telephone scripts Diaries, Assessments, Questionnaires Instructions for subjects (study-specific instructions not individual instructions such as appt. reminders, etc.) 7

8 IRB Essential Documents Investigator s Brochure To document that relevant & current scientific info about the investigational product has been provided to the investigator Maintain all revisions Deviation Reports Assessment of the cause of the deviation Ensure it does not happen again: training, change process, Corrective Action & Preventative Action (CAPA) Plans, etc. Ensure correct assignment of major/minor classification Serious Adverse Events submitted to the IRB and sponsor Initial submission, follow up submission, IRB acknowledgment letters IRB Committee Composition List (spanning duration of review of study) 8

9 FDA Essential Documents For drugs or biologics studies: Copy of Form FDA 1571 Cover sheet for all initial FDA submission and amendments to the IND Signed and dated by Sponsor-Investigator Start with serial number 0000 and then sequentially thereafter Copies of Form FDA 1572 Signed and dated by PI Updated as needed: PI & Sub-Investigator names, IRB, clinical sites, clinical labs Keep all revisions For device studies: Copies of Investigator s Agreement (every 6 months) Signed and dated by PI Updated as needed (as above) Keep all revisions 9

10 FDA Documents For drugs, biologics and device studies: Copies of Financial Disclosures provided to Sponsor Disclosures for PI and all Sub-Investigators Form FDA 3454 (Certification): To attest to the absence of financial interests and arrangements Form FDA 3455 (Disclosure): Disclosure of financial arrangements between investigator and sponsor, or investigator interest in tested product, etc. 10

11 JHS and UMH Essential Documents JHS Clinical Research Review Committee (CRRC) at the JHS Clinical Trial Office (CTO) approval documents: Studies testing a drug, device or biologic at JHS Procedures, lab tests (including blood draws) at JHS Review of JHS patient records Recruitment or referral of JHS patients Use of JHS research pharmacy or other JHS facilities University of Miami Hospital (UMH) Quality Department : Same as above but at UMH 11

12 Additional Essential Documents Qualification documents for PI and all key research personnel CITI Certifications (UM requirement is every 2 years) Medical licenses for physicians and nurses Current CVs for all study team members Certifications such as ACRP, SOCRA, Phlebotomy, etc. Study-specific training: Documentation of protocol review with study team, in-service Research-related training documentation Spanning duration of study or assignment to study Maybe maintained in a separate credential binder(s) with a documentation of where to locate these. 12

13 More Essential Documents Laboratory Credentials For all labs listed in protocol and on the 1572 (if applicable) Current and updated laboratory certifications (e.g. CLIA or CAP) Current and updated lab Director s CV & medical license(s) Normal values/ranges for all tests included in protocol Delegation of Authority Typically a table listing all study personnel and their assigned responsibilities as delegated by the PI: Required by ICH-GCP, strongly recommended by FDA (mentioned in guidance and audits) Lists all key personnel and Sub-Investigators Duties & responsibilities assigned by PI Informed Consent, physical exams, data entry, etc. Start date & end date for all personnel Include creation date Signed by PI: at start date and at end date for all study personnel Note: This is an active document that should be continuously updated to reflect personnel being added and removed from study. 13

14 More Essential Documents Subject screening & enrollment log: Required by ICH-GCP Randomization list Monitoring Decoding procedure for blinded trials» In case of emergency, identity of blinded investigational product can be revealed without breaking blind of remaining subjects Trial initiation monitoring report Monitor follow up letters - documents monitor site visits, deviations, action items Monitoring visit log(s) Corrective Actions Preventive Actions (CAPA), if any Correspondence ( s, etc.) with monitors 14

15 More Essential Documents DSMB plan (if applicable): including committee members DSMB reports: Determination of subject safety and continuation of trial Notification of SAEs From investigator to sponsor Include Documentation of submission within required timeframe From sponsor to investigator (External SAEs/IND Safety Reports) Findings that could adversely affect subject safety Findings that could impact the conduct of the trial or impact the IRB s favorable opinion to continue the trial See 21 CFR and for safety reporting 15

16 More Essential Documents Adverse Event Log (s) (recommended) Running log of SAEs, AEs and unanticipated problems Helps monitor the safety of subjects Helps to compile Continuing Reports Sponsor correspondences and/or communications: amendments, requests, queries Correspondences: with IRB, medical monitor, relevant s Research team meeting minutes (including agendas and sign in sheets) Case Report Forms (blank template) 16

17 More Essential Documents Investigational Product IP includes drugs, devices and biologics Instructions for handling investigational product (if not included in protocol or Investigator s Brochure) Includes instructions for storage, packaging, dispensing and disposition If the study team dispenses IP: Suggest to create a SOP on dispensing IP Must meet pharmacy requirements; includes: Procedures on handling, storage, dispensing and disposition of IP Record keeping of accountability logs Storage requirements: locked, limited access Temperature controlled environment Destruction of IP» Calibrated thermometers» Temp logs or charts» Emergency back-up power 17

18 More Essential Documents Investigational Product Shipping Records Shipment dates Lot/Batch numbers Method of shipment Shipping conditions Investigational Product Accountability Logs Amount dispensed Date dispensed Lot/batch number Name of personnel dispensing Name of recipient & date received Amount returned & date returned Disposition Investigational Product Temperature logs 18

19 Agreements/Contracts To document financial agreements: Grant proposal & award letter May list conditions for clinical trial Investigator/institution agreement with trial sponsor Recommendation to maintain in a separate binder 19

20 Maintaining the Regulatory Binder Organize binder with: Labeled cover: study # and title, PI name, volume #, etc. Sections: with labeled tabs Chronological order within sections Maintain a schedule for: Continuing Reports CITI re-certification due dates Update on a regular basis: Delegation of Authority Log Qualification documentation: CITI, medical licenses, CVs Subject Enrollment/Disenrollment Log *Keep all documents throughout the life of the study 20

21 Investigator held IND/IDE Studies: Sponsor-Investigator Responsibilities Investigators holding an IND/IDE have sponsor responsibilities in addition to investigator responsibilities Separate sponsor binder(s) containing IND/IDE submissions, annual reports, amendments, FDA correspondence, etc. 21

22 Recommended SOPs For research teams: Maintaining the Regulatory Binder Storage, handling and dispensing IP (if applicable) 22

23 Final Words Organize the regulatory/tmf binders: Chronological order Tell the story of your study such that an outside reviewer or new study team member can read it and understand what happened Maintain documentation of all approvals and re-approvals Update documents as needed: Form FDA1572, DOA log, training records, etc. The regulatory/tmf binders are continuously evolving throughout the study 23

24 Questions? 24

25 How to Contact us Office of Clinical Research Operations & Regulatory Support Telephone: (305) To report a problem or concern: https://canewatch.ethicspoint.com 25

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