Is a Clinical Trial Agreement (CTA) different from a Contract?
A CTA is a contract that covers clinical research with human subjects. It contains many of the same elements and obligations as set out for Contracts. A main difference is that when the governing protocol is developed by the sponsor, it is typical that the resulting Intellectual Property will be owned by the sponsor. If the CTA is based on an investigator initiated protocol, ownership of the results should vest in the researcher(s). There may also be restrictions on publication to allow for a multi-centre study publication to precede publication by one researcher/ centre. However, our researchers must always retain the right to publish their findings within a reasonable time frame.
What is the rate of indirect costs (overhead) associated with CTAs?
The rate for CTAs is 30% of total direct costs.
What is the ICMJE?
ICMJE is the International Committee of Medial Journal Editors. The Committee has developed policy that requires registration of a clinical trial in a public registry before the first subject is enrolled. For more information on this policy please visit: http://www.icmje.org/fag.pdf
Who can sign a CTA?
CTAs are signed by the Director of the Office of Research Services on behalf of Queen's. This is currently Dr. Susan Wood.
CTAs are co-signed by the relevant signatory at the participating affiliated hospital (KGH, Hotel Dieu, Providence Care).
Often researchers are asked to sign in addition to the institutional signatories, and this is acceptable.
What is the process for having a CTA signed?
In general, the process is as follows:
1. The CTA is provided by the researcher or the sponsor to the Manager, Research Contracts. This is currently Laurie Vaughan-Evans.
2. The CTA is assigned to a member of the Contracts Unit for review/ drafting.
3. Once reviewed, a copy and any related comments are provided to the researcher for their consideration. The researcher is requested to complete a Data Summary and Signature Sheet (DSS).
4. Proof of necessary certifications is requested. (e.g. Human Ethics, Animal Care, Biohazard Approval, Radiation Safety Approval )
5. A copy of the CTA and related comments are then provided to the sponsor, and the negotiation is undertaken.
6. Once agreement with the sponsor is reached on the terms, the Contracts Unit member will manage the signature process by Queen's, the affiliated hospital and the sponsor.
7. Upon execution, a copy of the CTA and DSS are forwarded to Financial Services so an account may be set up. At this point all questions related to the release of funds should be directed to the person in Financial Services who manages the account.
8. An original of the fully executed CTA is provided to the relevant hospital(s) contact.
9. A copy of the CTA is provided to the researcher and the relevant Department Head.
Amendments to CTAs follow much the same process as outlined above.