The TMF is the official record of the clinical study for Regulatory Authorities, be it…
7 Tips for efficient study start-up:
No.1) Involve Canadian oncologists early on and gather country-specific insight regarding possible enrollment barriers, competing therapies, and study design.
No.2) Exploit provincial REBs in order to optimize study start-up, and minimize unnecessary start-up work.
No.3) Carefully select which Site will act as provincial applicant for study approval:
- Confirm study Site staff experience, and ‘busy-ness’ at start-up;
- REB submission deadlines, meeting dates, position on review queue, and estimated turnaround times;
- Other required internal approvals (ex: scientific review, departmental impact assessments), and estimated turnaround times;
- Prior CRO experience with site team (historic start-up metrics);
- PI’s engagement, reciprocity, and ability to influence team and department.
No.4) Identify site-specific and Ethics Board language requirements for patient documents.
- When applicable, obtain required translations upfront (ex: ICF, diaries, pocket cards, study questionnaires, etc.).
No.5) Know REB specific policies in order to customize the study initial application and expedite study review/approval.
- Non-negotiable ICF language (ex: reproductive risks, confidential clause, etc.);
- Preferred ICF language (ex: including or not risks associated to standard or care procedures; details required for study vendors and study systems, references to prior study data, etc.);
- Study documents required for initial review (ex: Health Canada NOL needed or not?);
- Details required for study vendors and study systems (ex: from none needed, to complete address and information on their SOPs).
No.6) Conduct start-up activities in parallel when possible, in order to avoid delays (ex: contract and budget negotiation in parallel to REB submission).
No.7) Work with site teams in order to gather essential documents required for study drug release and official site activation.
Oh… and involve Canada from the get go!!!!
Contributed by: Ms. Julie Martin, Director, Clinical Operations