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Randomized Controlled Trials (2006-2007) (Archived)
Change to Competition Deadline Schedule for Randomized Controlled Trials Program
In light of budget limitations and in recognition of the number of full applications expected for submission to the RCT program during 2007-2008, CIHR has taken the operational decision to hold only 2 competitions for full applications to the RCT Program in 2007-2008. Full applications will only be accepted for the September 1, 2007 (Registration deadline: August 1, 2007) and February 15, 2008 (Registration deadline: January 15, 2008) competitions.
To ensure that high quality applications continue to be developed for funding as Full applications in future years, RCT Outline applications will continue to be accepted at the usual deadline dates of August 1, 2007; October 1, 2007; January 15, 2008 and March 1, 2008.
Applicants considering RCT submissions for industry-partnered competitions, RFAs, Strategic Initiatives or Priority Announcements, or other unique funding opportunities may submit their applications to any of the four competition dates that are offered. It should be understood by applicants that the usual RCT guidelines are to be followed, and that any other requirements imposed by the unique funding opportunities are also met.
Description
A randomized controlled trial (RCT) is an experiment in which investigators randomly assign eligible subjects (or other units of study, e.g. classrooms, clinics, playgrounds) into groups to receive or not receive one or more interventions that are being compared. The results are analysed by comparing outcomes in the groups. Applications will be examined for the relevance of the question posed, and the appropriateness of the methodology and of gender representation in the study design and selection of research subjects.
Applications for dose finding studies, safety and efficacy studies and other non-randomized clinical studies must be made through the CIHR Operating Grants Program, and will be reviewed by the relevant content committee. (Please refer to the Partnerships Programs guidelines for those applications funded in part by Industrial Partners.) CIHR will not provide support for studies that are solely for the purpose of satisfying regulatory requirements.
There are 4 competitions a year for this program with application deadlines for Full Applications of: September 1, November 1, February 15, and April 1. More information can be found in the funding opportunity titled "Randomized Controlled Trials".
Notes about CIHR deadlines:
- Deadline dates indicate the latest acceptable date for a courier-stamped application.
- If the deadline date falls during a weekend or a holiday, the deadline will be the next working day.
Randomized Controlled Trials Competition Cycle
Table 1 - RCT Outline
| RCT Outline | |
| Deadline Dates | August 1 October 1 January 15 March 1 |
| Research Module | Routing slip, page 1, page 2a, page 3, pages 5-7, page 9, page 11(a,b) if applicable, page 12 (Research proposal numbered page 12a-12m. Use headings for RCT Outline). Research proposal appendices are not permitted. |
| Applicant consent form | Nominated Principal Applicant to complete and sign. |
| Signature Page of Research Module (Page 2a) |
|
| CV Module |
Draft versions of the CV modules will NOT be accepted. It is the responsibility of the Nominated Principal Investigator to ensure that all CV modules submitted with the application are the validated versions. |
| Operating Budget Module | For industry-partnered RCTs ONLY |
|
Industrial Partnership Module |
For industry-partnered RCTs ONLY. |
| Number of copies Required | Original and 8 copies (of each module) or original and 9 copies for industry-partnered RCTs. |
RCT Outline
An RCT Outline is a letter of intent which is peer reviewed by the Randomized Controlled Trials committee. The results of the review assist CIHR and the applicants in identifying those ideas that are likely to be competitive, and to provide constructive feedback for a Full Application or subsequent proposals. Studies that are recommended to proceed to a Full Application are not, of course, guaranteed eventual support.
First-time applicants to the Randomized Controlled Trials program or applicants who have never held a CIHR RCT Program grant as Principal Investigator must submit an RCT Outline. Principal Applicants who have held, or hold an RCT or Clinical Trial grant are not required to submit an RCT Outline, although it is encouraged. Renewal applications do not require a prior RCT Outline submission
However, submission of an RCT Outline is required for all Randomized Controlled Trials in which the total budget is $2 million or greater, AND/OR the annual budget is $500,000 or more, AND/OR the duration is greater than 5 years AND/OR international collaboration is proposed OR an industry-partnered application is proposed. Full Applications for industry-partnered projects OR projects fulfilling any of the above-mentioned conditions will be accepted only if they have been successful at the RCT Outline stage.
The RCT Outline submission utilizes the standard CIHR application modules with specialized instructions for their completion (see Table 1).
RCT Outlines must be submitted by the deadlines given in Table 1. Results will be available approximately 5 months later. Decisions will be announced officially about one month after that. Thus, the earliest possible date for applicants with successful RCT Outlines to register their intent to submit a Full Application is approximately 6 months following the submission of the RCT Outline. The latest date to register their intent to submit a Full Application is one year from the notification of a successful RCT Outline. The usual Full Application deadlines would then apply.
Table 2 - Full Application
| Registration for a Full Application | Full Application | |
| Deadline Dates | August 1 October 1 January 15 March 1 |
September 1 November 1 February 15 April 1 |
| Research Module | Routing slip, pages 1, 2a, 3, 5-7, 9. |
Routing slip, page 1(all signatures required), pages 2a, 3-7, page 9, pages 10 & 11(a,b) if applicable, page 12 (Research proposal numbered 12a-12m. Use headings for Full Application), research proposal appendices (35 page maximum). Research module Appendix 1, 2 & 2a, as needed). |
| Applicant consent form | Nominated Principal Applicant to complete and sign | Nominated Principal Applicant to complete and sign |
| Signature Page of Research Module (Page 2a) |
Nominated Principal Applicant original signature only. Names of all Principal Applicants and Co-Applicants. |
Original signatures from Nominated Principal Applicant and any other Principal Applicants and Co-Applicants. |
| CV Module |
From all Principal Applicants and Co-Applicants, pages 1 and 2. Nominated Principal Applicant original signature only. |
Full CV Module for Nominated Principal Applicant and any other Principal Applicants and Co-Applicants, properly signed by each. Draft versions of the CV modules will NOT be accepted. It is the responsibility of the Nominated Principal Investigator to ensure that all CV modules submitted with the application are the validated versions |
| Operating Budget Module | N/A | All Pages. |
| Industrial Partnership Module | N/A | Full Industrial Partnership Module with proper signatures. |
| Number of copies Required | 1 original and 2 copies (of each module). | 1 original and 8 copies (of each module). |
Full Application
Applicants whose RCT Outline was recommended to proceed to a Full Application must register their intent to apply. Applicants must also register their intent to apply for all new or renewal Randomized Controlled Trial Grants. In both cases, registration must be made one month before the deadline date for the Full Application.
Submission of Full Applications utilizes the standard CIHR application forms with specialized guidelines for the completion of the Research module. Guidelines and forms are available elsewhere on CIHR's website.
CIHR will consider the provision of funds for feasibility testing, pilot projects, the expenses of monitoring committees and, when specially justified, for the coordination of major multi-centre trials
CIHR will allow funds to be used to support non-Canadian centres when the trial is clearly a Canadian initiative and the majority of centres are located in Canada. In such cases, the applicants must justify the inclusion of foreign sites within the context of a RCT Outline application prior to the submission of a Full Application.
Within the Randomized Controlled Trials Program, the review committee has the discretion to assign an "under continuing review (UCR)" rating to those applications where there is/are minor concern(s) or additional information/clarification is required to complete the review process. Following the peer review meeting, the relevant principal applicants are asked to respond to specific questions which are subsequently reviewed and assessed by the committee on an ad-hoc basis. Due to this process, announcement of the successful grants in this program may be delayed beyond the regular CIHR timelines.
If you have any questions, please contact:
Canadian Institutes of Health Research
Room 97, 160 Elgin St.
Address Locator 4809A
Ottawa ON K1A 0W9
Tel: (613) 957-6137, E-mail: ichikuru@cihr-irsc.gc.ca, or
Tel: (613) 941-4438, E-mail: tgasparini@cihr-irsc.gc.ca, or
Tel: (613) 941-0718, E-mail: ischweitzer@cihr-irsc.gc.ca, or
Tel: (613) 957-8668, E-mail: gvallee@cihr-irsc.gc.ca
Fax: (613) 954-1800
