Essential Documents for Clinical Trial Research. Centre for Health Evaluation and Outcome Sciences Manager, Clinical Research Development Office

Transcription

1 Essential Documents for Clinical Trial Research Erin Cherban, MSc., CCRP Centre for Health Evaluation and Outcome Sciences Manager, Clinical Research Development Office

2 Document Examples See the following examples at the end of this presentation: GCP Guidance, Section 8 Trial Master File Documents Note-to to-file template

3 Documentation Documentation is critical in clinical research. Protect yourself and your staff by following this rule: If it s s not written down, it did not happen

4 What are essential documents? Essential Documents are those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standard of GCP and with all applicable regulatory requirements. Source: The International Conference on Harmonization, Topic E6: Good Clinical Practice: Consolidated Guideline, Section 8.

5 Where to seek guidance? The International Conference on Harmonization, Topic E6: Good Clinical Practice: Consolidated Guideline Website: sc.ca/dhp-mps/prodpharma/applic-demande/guide- ld/ich/efficac/e6_e.html

6 GCP Consolidated Guideline = Minimum list of documents

7 Essential documents GCP Guidelines are suitably vague, your site s s trial master file must include the documents unique to your site: National: Health Canada No Objection Letter. Local: Fraser Health approval documents including Letter of Authorization to Conduct Research. Sponsor: Data queries, monitor s s reports, and adverse event reports.

8 Documentation Controlling paper work vs. A satisfied site, sponsor and regulatory authorities = Trial Master File

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10 Trial Master File At the beginning of the trial determine the space and filing logistics for your site. Space: Where can you retain the documents in a secure fashion? Where can you store documents that are not needed day-to to-day? Filing: What is your preferred method, what is your sponsor s s preferred method? Discuss at outset of the trial. Establish a system at the beginning of the trial, your files will remain organized.

11 Trial Master File Filing: Keep files in chronological order. Neat and complete files. A paper trail explanation of all aspects of the trial. Update files continuously. Do not discard older documents, store them.

12 The paper trail. Consider documenting: 1) Evidence of supervision of trial responsibilities For example: agendas and minutes from research team meetings. investigator decisions about trial related procedures and subjects (consider or a more formal meeting with notes)

13 The paper trail. 2) Your site s s standard operating procedures (SOPs) A Health Canada auditor will look for documented proof of your site s procedure for the informed consent process. They will also look for documented proof that each subject is eligible for the trial.

14 The paper trail. 3) Subject visit tools/checklists and notes Use or create subject visit tools to include in the subject s s study file (for example, lab test and procedures required at the visit). Keep written, detailed progress notes of each study visit.

15 The paper trail. 3) 25 Year Document Retention Requirement For trials authorized by Health Canada you need proof that the trial documents will be retained for 25 years. Ask the sponsor for this documentation (at the beginning of the study this will remind you to discuss long-term archiving responsibilities and costs).

16 The paper trail. 4) Protocol Deviations Remember to report protocol deviations to your ethics committee and sponsor.

17 The paper trail. 5) Use Note s-to to-file A helpful tool to record everything from discrepancies to the physical location of files. Remember: It is okay if you make a mistake, but document it and include corrective action. Do not hide it.

18 The paper trail. 5) Regularly print your s and file them rather than trying to remember what was important at a later date. 6) Use any method/format that works for your site/investigator but remind everyone that without a paper trail, there is no audit trail.

19 Keep your Files Current Designate a staff member to update files: Delegation of responsibility/signature log signed and dated as needed Current CVs and medical licenses Continuing education for all personnel Lab normals and accreditation

20 Keep your Files Current Calibration of study equipment SAE log or regulatory submission log Subject screening, enrolment and identification logs. Move older versions of the investigator s brochure, protocol and informed consents into on site storage.

21 Simplify your files... Create a central file for documents used in many studies, for example: CVs and medical licenses Staff continuing education In your trial master file, reference the location of these documents using a note-to to-file.

22 Storage/Archiving Consider on-site archiving of documents that are out-dated, but that must be retained. For example, move older versions of the protocol and informed consent, this will prevent confusion and create space for day- to-day documents. Document the location with a note-to to-file in your trial master file.

23 Key Subject Documents Source documents Completed case report forms AEs and SAEs

24 Thank you Questions? Tel: