Clinical Research Records Documentation, Maintenance and Storage

Transcription

1 CNE Disclosures 1 Successful Completion: Participants must complete an evaluation form to receive a certificate of completion Contact Hours: 1 contact hour is available to those who meet the successful completion requirements Sponsorship & Commercial Support: This activity has received no sponsorship or commercial support Conflict of Interest: No conflicts of interest were identified Non-Endorsement: Accreditation approval refers only to MONAs continuing education activities and does not imply MONA or ANCC Commission on Accreditation endorsement of any commercial products Off Label Use: There will be no discussion of uses of products other than what is approved by the FDA. Expiration: Contact Hours expire on October 29, 2015 Clinical Research Records Documentation, Maintenance and Storage KRISTIN GEILE DEPARTMENT OF SURGERY MICKEY CLARKE OFFICE OF THE VICE CHANCELLOR FOR RESEARCH 1

2 Clinical Trial Records All Clinical Trial information should be recorded, handled, and stored in such a way that it can be accurately reported, interpreted and verified We should be able to adequately reconstruct the trial activities undertaken by review of the clinical trial records Records should reflect a stand-alone set of documentation that does not require additional explanation from the associated sponsor or site staff Place documents in the regulatory file in a timely manner with the aim to remain inspection ready Essential Documents Documents which individually & collectively permit evaluation of the conduct of a trial & the quality of data produced Serves to document compliance of the Investigator, Sponsor and CRO with GCP standards and regulatory requirements These Documents are frequently audited by the sponsor/monitor and regulatory authorities to confirm the validity of the trial conduct and the integrity of the trial data 2

3 Record Keeping and Retention Regulatory Binder(s) Research Subject Binder(s) It is the PI s responsibility to maintain these records Set up files at the beginning of the trial and maintain them throughout the conduct of the trial Files should be organized, complete, easy to follow Paper or electronic files may be acceptable Timelines for record retention can depend on multiple sources (Federal Regulations, Sponsored project contract stipulations, IRB policies, University policies ) (Pre-trial) Essential Documents Investigator Brochure (relevant and current scientific information about the investigational product, PI signature confirms receipt) Protocol Signature Page (document investigator and sponsor agreement to the protocol/amendment(s)) CV/License of PI and Sub-Investigators (to document qualifications to conduct trial and provide medical supervision of subjects) Information that will be given to the subject (Informed Consent document, advertising/recruitment tools) 3

4 (Pre-Trial) Essential Documents Financial Documents (Signed Financial Disclosure Forms, Clinical Trial Agreement/Contract as applicable) IRB approval (Should include date of IRB approval, version number and date of the approved protocol) IRB membership/composition (Provide/File WU s Federal Wide Assurance letter) FDA approval (when applicable, IND, IDE trials) Normal Value Ranges (Laboratory, Other tests included in the protocol) Instructions for Use (instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational products and trial-related materials) Delegation of Authority Log (During Trial) Essential Documents Investigator Brochure updates Signature page IRB approval Training records Applicable Informed Consent changes (Re-consent of Subjects as required) Protocol Amendments Signature page IRB approval Training records Applicable Informed Consent changes (Re-consent of Subjects as required) FDA approval letters/cms approval letters for IDE trials 4

5 (During Trial) Essential Documents Annual Renewals/modifications IRB approval Notify Study Team of New Approved Consent forms Print Consent documents from myirb CV & Licenses (Update as needed) Keep current, update CV every 2 years, Licenses as applicable Central file-note-to-file for location (During Trial) Essential Documents Changes to the study team Modification in myirb CV, License, FDF, 1572 (if applicable) for New Investigators Start dates, Stop dates on Delegation of Authority Log Documentation of training for new study members Monitoring Reports (document site visits by, and findings of, the monitor) This is Your report card! Relevant Communication/Correspondence 5

6 (During Trial) Essential Documents Essential Logs (Keep Current and Complete) Screening Log Enrollment Log Master Randomization List, if applicable Device/Drug Accountability Logs Monitor Visit(s) Log Training Log (as applicable) Delegation of Authority Log (as personnel changes are made) Deviation Log Adverse Event Log Communications/ Correspondence (Post-trial) Essential Documents Investigational Product Accountability Log (documents the final accounting of investigational product(s) received at the site, dispensed to subjects, returned by the subjects, destroyed or returned to sponsor) Completed Subject Enrollment Log Close-Out Monitoring Letter (to document that all activities required are completed, and copies of essential documents are held in the appropriate files) Final Report (as applicable) FDFs may be required 1 year following the close of the trial To decrease risk of misplacement of documents Limit access to study staff (and monitors, auditors and inspectors) Retain files as applicable 6

7 Regulatory Document File Organize your files Chronological, newest documents in front Use tabs to delineate sections of the binder (protocol, IB, FDFs, IRB, correspondence) Create notes to file when documents are to be placed elsewhere (i.e. central file for CVs) Forward updated essential documents, IRB approvals, changes to logs to the study sponsor Participant Research Record Keep an organized binder/folder for each subject Keep original signed Informed Consent (*signed and personally dated by the subject or LAR and signed and personally dated by the person who provided informed consent/conducted the informed consent discussion) ICH and WU policy-subject should receive a copy of the signed and dated written consent document Document the informed consent process (narrative) best practice Document that the subject met eligibility criteria (have source documents on hand; signed by PI if applicable) 7

8 Documentation of Consent Process Note in the research file describing discussion of study consent Typical industry sponsor requirement Not mentioned in 45CFR 46 Not mentioned in ICH E6 (Good Clinical Practice) FDA: In those cases where the subject provides consent on the same day that he/she begins participation in the clinical investigation, the subject's case history must document that the subject provided consent prior to participation in the research (see 21 CFR (b) and 21 CFR (a)(3)). Source Documents Document the existence of the subject and substantiate integrity of trial data collected Original documents related to the study (medical record, note to file, original source document where first notation is captured) Electronic Medical Records (print, verify as original) Laboratory results Operative reports EKG Imaging Reports/Radiology 8

9 Participant Research Record Study Visits (Documentation from each study required visit including all applicable source documents) CRFs (paper vs. direct Electronic entry) SAE documentation related to that particular subject *including appropriate notification to sponsor & IRB Unanticipated problems-documentation related to particular subject Relevant correspondence (file documentation necessary for reconstruction of key trial conduct activities and decisions or that contains other significant information). Sponsors, CROs and investigators should consider the value of a document in this regard when deciding to file it. File Chronologically. Participant Research Record Identifiable or Deidentified Information myirb question X Information in the research record Informed Consent Source documents Lab reports Radiology Reports Any method can be approvable, but must follow approved method 9

10 Documenting PI Oversight How will PI provide subject oversight? Review participant eligibility (as applicable) Sign eligibility checklist Review research data in EMR Print reports PI to initial (or sign) and date the report PI to determine Clinically Significant (CS) Not Clinically Significant (NCS) Review of Serious Adverse Events Determine relationship to study product or procedures Documenting PI Oversight How will PI provide research team oversight? Participation in routine research team meetings *document minutes/attendance Training records Complete and accurate delegation log Review of Monitor Letters (PI signature and date) Availability to meet with monitor during visits 10

11 Research Records Risks of poor record keeping Poor record keeping raises auditor concerns regarding the PI s ability to manage and oversee the trial conduct Time is wasted when required documents cannot be located or need to be reproduced If it isn t charted, it wasn t done concept Creates a need for frequent notes to file to clarify missing information (raises further concerns for auditors) Paper vs. Electronic Files myirb Does submission need to be printed? Industry Monitor will need to review Paper Flash Drive Must be readily available for audit/inspection by monitor or regulatory authorities Investigator Initiated Single site or Multi-site Internal or External monitor (monitor expectations) NIH Single site or Multi-site Internal or External monitor (monitor expectations) 11

12 Paper versus Electronic Files Concurrent with the increased use of EMR (electronic medical record) is the increased use of electronic capture of data in clinical research More widespread use of electronic data capture (EDC) systems by sponsors Use of an IPad to directly capture patient data or direct entry of a questionnaire into the EDC Use of central portals for uploading regulatory documents Paper versus Electronic Files Paper records have disadvantages They take up space Not eco-friendly Can deteriorate over time with excessive handling and/or environmental factors Sharing requires mailing, faxing or scanning then ing Typically there is only one copy (without backup files) Paper record advantages Source documents like the EMR have more information than might be relevant to the trial, the paper research file can be organized without this excess Generally secure unless someone deliberately breaks in to access 12

13 Paper versus Electronic Files Electronic records have advantages Stored on computer drives or servers Can be stored forever theoretically without deterioration of quality Easier accessibility (instant sharing via electronic transmission) It is considered general practice to have a back-up copy Electronic records disadvantages Susceptible to unauthorized individuals who can gain access by breaking down the electronic defenses of a storage system Can be inaccessible during system crashes or other electronic malfunctions Technology changes (floppy drive, CD, cloud) Clinical Research Records QUESTIONS OR COMMENTS? 13