Timelines: The median time to complete Clinical Trial Agreement (CTA) review between the date that the CTA was sent to and when negotiations were completed by UBC was 31 business days with a mean of 54 business days in 2007-08.

Please review the following process to ensure the most efficient service.

CTA Submission:

1. The Fraser Health clinical trial site submits a word document of the draft CTAs and the Site Administrative Information Form by email to Susan Chunick.

All draft CTAs must be submitted as an editable version (preferably MS Word) and unlocked or accompanied by a password to unlock for review and editing and without signatures.
It is the site’s responsibility to obtain an editable version from the sponsor.
We will not accept draft CTAs if submitted directly by a sponsor.

2. The Fraser Health site is responsible for ensuring that all of their site’s requirements are included in the CTA prior to submission, e.g. payee information , Sponsor contracts contact information.

3. The budget may be developed by the site with the sponsor while the CTA is being negotiated.

Upon receipt:

4. Site administration form reviewed for completeness. Accurate completion of this form will ensure that the correct administrative and payee information is included in the clinical trial agreement.

5. Insurance certificates are required for industry-sponsored research only; not for academic sponsored research. Insurance certificates that are not available at the time of submission must be submitted before the CTA is signed off.

Within 2 business days:

6. Draft CTA with any comments is forwarded to the UBC Contract Manager who conducts all negotiations with the sponsor on behalf of Fraser Health. CTA is only forwarded if the application for ethical review has also been received by the Fraser Health Research Ethics Board.

7. All correspondence with the sponsor is copied to the Fraser Health site administrative contact identified on the site administrative form and to Susan Chunick.

Within 10 business days :

8. Review by UBC Contract Manager who notifies the sponsor of required revisions follows up with sponsor every 10-15 business days, on behalf of Fraser Health. Negotiations continue until FH requirements are satisfied. Note that negotiations are done on behalf of Fraser Health only.

9. Contract Manager makes recommendations to Fraser Health and also advises if there are any concerns that require an executive decision prior to recommending acceptance of the CTA.

Prior to CTA Finalization:

10. Review and finalization of the study budget is a responsibility only of the Fraser Health research site and the sponsor, and does not include review by the Contract Manager.

- The study budget must be agreed to by both the Fraser Health research site and the sponsor before the CTA is considered finalized.
- However, the sponsor and research site may choose to amend the budget at a later date if the budget is not finalized by the time that the legal content of the CTA is approved.

11. Fraser Health site reviews and approves final CTA.

12. Susan Chunick, Director reviews final CTA and insurance certificate(s) before beginning signature rotation.

- Fraser Health site must ensure that the insurance certificate for the study is submitted before final review.

Signature Rotation:

13. Sponsor sends # of required copies, as specified in the Site Administrative Form, directly to Camille Viray, Administrative Assistant .

14. Note that CTA copies are circulated for signature only when the Fraser Health Research Ethics Board has issued the certificate of ethical approval for initial ethical review or requires modifications only.

15. Minimum of 3 originals of the CTA are required and should be signed in the following order: sponsor, Fraser Health signatory and principal investigator.

16. Within three business days, Fraser Health Vice-President signature is obtained.

Within one business day:

17. Signed CTA’s are couriered to the Fraser Health site for signing.

- Fraser Health site is responsible for forwarding onto the sponsor.

CTA Follow-up:

18. Administrative Assistant follows up every 10 business days until a complete signed copy of the CTA is returned to Fraser Health.

Fraserhealth.ca

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