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 2006-2007, CIHR has taken the operational decision to hold only 2 competitions for full applications to the RCT Program in 2006-2007. Full applications will only be accepted for the September 1, 2006 (Registration deadline: August 1, 2006) and February 15, 2007 (Registration deadline: January 15, 2007 ) 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, 2006; October 1, 2006; January 15, 2007 and March 1, 2007.
For more information, please consult the Funding News and Developments section.
For your convenience, please print these Guidelines:
1. Information about CIHR Randomized Controlled Trials
2. Responsibilities of Applicants
3. Acceptable Application Module Formats
4. Mandatory Instructions for Data Entry
5. Randomized Controlled Trials Competition Cycle
6. Guidelines for Completing a RCT Outline
7. Guidelines for Completing Registrations and Full Applications
8. Compiling the Modules into an Application Package
9. Where to send the RCT Outline, the Registration, and the Full Application, and CIHR Contacts
CIHR recognizes the importance of randomized controlled trials as a tool to provide high quality evidence on the efficacy and effectiveness of interventions in health and health services. This includes, but is not limited to the following types of interventions: Behavioral, Knowledge Translation, Complementary and Alternative Healthcare, Devices, Diagnostic, Educational, Health Services, Lifestyle, Medical Management Strategies, Pharmaceutical, Population Health, Preventative, Psychosocial, Surgical, Other therapeutic procedures. It also recognizes the complexity of designing, co-ordinating and monitoring trials and the importance of incorporating their results into practice. The CIHR Randomized Controlled Trials procedures are aimed at ensuring that public money is spent on well-managed trials of only the highest scientific quality, are safe for participants and are ethically sound. The procedures are designed to help those involved in the design and management of trials and to assist those who are involved in deciding which trials should be funded through the peer review process.
The guidelines and procedures for application to the Randomized Controlled Trials Program have been tailored to examine two sets of questions:
1. Is there a real need for the trial?
2. Is the study team, design, methodology and trial management robust ?
CIHR offers researchers a variety of programs. To ensure the success of their applications, applicants must:
Currently, CIHR has both Web forms and PDF forms for applications for funding.
Effective January 1, 2005, all applicants must use the Web Form application modules when applying for funding for all CIHR programs. Inputted PDF fillable forms will only be accepted where a corresponding web form does not exist. Hand-written applications will not be accepted. PDF forms for which there is an equivalent web form will remain on CIHR's web site to serve only as visual examples.
Only the latest version of CIHR forms will be accepted. Version dates can be found at the bottom left corner of each page of the CIHR forms. Note that enhancements are made to the CIHR Web forms in June and December of each year. Please visit the CIHR Web forms Website for the most up-to-date version of the CIHR Web forms.
The CIHR Web forms ensure that the information entered is saved in a secure and private database that you can access at any time, from a computer, using an Internet browser and your PIN and password. The CIHR Web forms do not display all the information on a single screen and data is entered in distinct and separate sections. The reason that data entry is broken into distinct sections on the web is to provide the flexibility to complete and save different sections at different points in time.
The use of Web forms increases CIHR's efficiency in processing applications and reduces researchers' workload in completing applications since the saved data can be reused and modified for future submissions. Other web form advantages include the ability to use drop-down menus where selecting an item automatically inputs that item into the data field thus reducing the amount of typing required, and the availability of links to pertinent information that can assist researchers in completing their submissions (e.g., links to guidelines for completion, priority announcements, FAQs and important notices).
File attachments may be prepared in the word processing software package of your choice, printed and included in the application form. Please follow the guidelines that are contained within the specific Web Form application modules for formatting each page of an attachment.
At this time, CIHR Web forms cannot be submitted electronically, therefore the completed forms must be printed out, signed by the appropriate officials and the copies sent to CIHR (Exception: In the March 2005 competition, CIHR is planning to pilot a new application process for the electronic submission for applications to the Behavioural Sciences or Neurosciences peer review committees. For these pilot participants, only the original, signed application needs to be sent to CIHR; extra copies are not required.)
Application modules which must be completed using CIHR's Web forms are:
Failure to follow these guidelines may result in the administrative withdrawal of the following:
Application modules which have no web form equivalent must be inputted directly into a fillable PDF form. In order to save a fillable PDF form with filled-in text, you will need "Adobe Writer". [ Help ] Hand-written applications will not be accepted. These guidelines apply to the following fillable PDF forms:
There are no plans at this time to provide Web forms for the above fillable PDF forms. For further information, please direct your inquiries to info@cihr-irsc.gc.ca or telephone (613) 954-1968.
Access All Forms and Guidelines for Completion
If applicants use Web forms, the font and point size for the text on the form is predetermined and cannot be changed. As well, if you use Web forms, the information required at the top and bottom of each page of the module will be automatically filled in for you after you have entered the information (for example-your name) in the appropriate sections.
CIHR offers applicants the opportunity to create text for any attachments with the word processing software of their choice or with a typewriter. All documents must be written and formatted following strict guidelines. The reason for these formatting requirements is to ensure that all applicants have exactly the same amount of space to make their proposals within the competition. This also facilitates the work of peer reviewers who must review multiple applications. CIHR indicates, under each section, the page number the section must have and the total number of pages permitted.
Mandatory Instructions for the preparation and the formatting of documentation. Failure to follow these instructions may result in the administrative withdrawal of your application.
Print must be of letter quality and easy to read.
Table 1 RCT Outline
| RCT Outline | |
| Deadline Dates | Aug 1 Oct 1 Jan 15 Mar 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). Appendices are not permitted. |
| Applicant consent form | 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. |
| CV Module |
- Full CV Modules from all Principal Applicants and Co-Applicants. 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. |
Table 2 Full Application
| Registration for a Full Application | Full Application | |
| Deadline Dates | Aug 1 Oct 1 Jan 15 Mar 1 |
Sept 1 Nov 1 Feb 15 Apr 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 Partnership & Industry Module with proper signatures. |
| Number of copies Required | 1 original and 2 copies (of each module). | 1 original and 8 copies of each module (9 copies for industry-partnered applications). |
Table 1 RCT Outline
| RCT Outline | |
| Deadline Dates | Aug 1 Oct 1 Jan 15 Mar 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). Appendices are not permitted. |
| Applicant consent form | 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. |
| CV Module |
- Full CV Modules from all Principal Applicants and Co-Applicants. 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.
Please structure your RCT Outline using the headings provided below. This enables the applicant to provide the information required for peer review. Make an entry under every heading. Failure to use the headings will result in the administrative withdrawal of your Outline application.
1. THE NEED FOR A TRIAL
1.1 What is the problem to be addressed?
1.2 What is/are the principal research question(s) to be addressed?
1.3 Why is a trial needed now? Evidence from the literature - see 1.4 below, professional and consumer consensus and pilot studies should be cited if available.
1.4 Give references to any relevant systematic review(s)1 and discuss the need for your trial in the light of the(se) review(s). If you believe that no relevant previous trials have been done, give details of your search strategy for existing trials.
1.5 How will the results of this trial be used? E.g. Inform decision-making /improve understanding.
2. THE PROPOSED TRIAL
2.1 What is the proposed trial design? E.g. Open-label, double or single blinded, etc.
2.2 What are the planned trial interventions? Both experimental and control.
2.3 What are the proposed practical arrangements for allocating participants to trial groups? E.g. Randomization method. If stratification or minimisation are to be used, give reasons and factors to be included.
2.4 What are the proposed methods for protecting against other sources of bias? E.g. Blinding or masking. If blinding is not possible, please explain why and give details of alternative methods proposed or implications for interpretation of the trials results.
2.5 What are the planned inclusion/exclusion criteria?
2.6 What is the proposed duration of treatment period?
2.7 What is the proposed frequency and duration of follow-up?
2.8 What are the proposed primary and secondary outcome measures?
2.9 How will the outcome measures be measured at follow-up?
2.10 What is the proposed sample size? Include both control and treatment groups, a brief description of the power calculations detailing the outcome measures on which these have been based, and give event rates, means and medians, etc., as appropriate. What is the justification for the size of difference that the trial is powered to detect? Does the sample size calculation take into account the anticipated rates of non-compliance and loss to follow-up given below; see sections 2.12 and 2.13?
2.11 What is the planned recruitment rate? How will recruitment be organised? Over what time period will recruitment take place? What evidence is there that the planned recruitment rate is achievable?
2.12 Are there likely to be any problems with compliance? On what evidence are the compliance figures based?
2.13 What is the likely rate of loss to follow-up? On what evidence is the loss to follow-up rate based?
2.14 Give details of the planned analyses.
2.15 Are there any planned subgroup analyses?
2.16 What is the proposed frequency of analyses? (Including any interim analyses.)
2.17 Will the trial address any economic issues? (This is not a requirement. However, please justify the inclusion/exclusion of any health economic studies and give details of any study proposed.)
2.18 What is the estimated cost and duration of the trial?
3. DETAILS OF TRIAL TEAM
3.1 Trial management. Briefly describe the role of each applicant proposed. Please indicate whether a Data Safety and Monitoring Committee will be established and describe its composition.
3.2 International Collaboration (if applicable). Please discuss the nature of and need for any international collaboration.
3.3 Participating centres. Please list the proposed participating centres.
4. OTHER FUNDING SOURCES
Provide name(s) and dollar figure(s) for funding being sought from other potential funders, including industry.
Evaluation of the RCT Outline
In assessing the RCT Outline, the reviewer will be attempting to answer the following broad questions:
The headings on the RCT Outline are structured to ensure that the key information required to assess the trial is present. Listed below are key questions that will be taken into account when assessing each section of the RCT Outline.
Section 1 - The need for a trial
Has the importance of the issue been adequately explained in terms of:
Section 2 -The proposed trial
Section 3 - Details of the trial team
OTHER IMPORTANT ISSUES
If you have any questions, please contact:
Canadian Institutes of Health Research
Room 97, 160 Elgin Street
Address locator: 4809A
Ottawa, Ontario K1A 0W9
Tel: (613) 957-6137, E-mail: ichikuru@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, or
Tel: (613) 941-4438, E-mail: tgasparini@cihr-irsc.gc.ca
Fax: (613) 954-1800
Registration provides CIHR with the basic information needed to identify, in advance, committee and potential external reviewers, which leads to a more effective peer review process.
Please take note of the submission deadlines for registrations and Full Applications, as given in Table 2, below.
Table 2 Full Application
| Registration for a Full Application | Full Application | |
| Deadline Dates | Aug 1 Oct 1 Jan 15 Mar 1 |
Sept 1 Nov 1 Feb 15 Apr 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 have been validated. |
| Operating Budget Module | N/A | All Pages. |
| Industrial Partnership Module | N/A | Full Partnership & Industry Module with proper signatures. |
| Number of copies Required | 1 original and 2 copies (of each module). | 1 original and 8 copies of each module (9 copies for industry-partnered RCTs). |
Please structure your Full Application using the headings provided below. Make an entry under every heading. Failure to use the headings will result in the administrative withdrawal of your full application.
1. THE NEED FOR A TRIAL
1.1 What is the problem to be addressed?
1.2 What is/are the principal research question(s) to be addressed?
1.3 Why is a trial needed now? Evidence from the literature - see 1.4 below, professional and consumer consensus and pilot studies should be cited if available.
1.4 Give references to any relevant systematic review(s)1 and discuss the need for your trial in the light of the(se) review(s). If you believe that no relevant previous trials have been done, give details of your search strategy for existing trials.
1.5 How will the results of this trial be used? E.g. Inform decision making/improve understanding.
1.6 Describe any risks to the safety of participants involved in the trial.
2. THE PROPOSED TRIAL
2.1 What is the proposed trial design? E.g. Open-label, double or single blinded, etc.
2.2 What are the planned trial interventions? Both experimental and control.
2.3 What are the proposed practical arrangements for allocating participants to trial groups? E.g. Randomization method. If stratification or minimization are to be used, give reasons and factors to be included.
2.4 What are the proposed methods for protecting against sources of bias? E.g. Blinding or masking. If blinding is not possible please explain why and give details of alternative methods proposed, or implications for interpretation of the trial's results.
2.5 What are the planned inclusion/exclusion criteria?
2.6 What is the proposed duration of treatment period?
2.7 What is the proposed frequency and duration of follow up?
2.8 What are the proposed primary and secondary outcome measures?
2.9 How will the outcome measures be measured at follow up?
2.10 Will health service research issues be addressed? Justify inclusion/exclusion of health economics and quality of life measures. If these measures are to be included full details should be given including power calculations.
2.11 What is the proposed sample size and what is the justification for the assumptions underlying the power calculations? Include both control and treatment groups, a brief description of the power calculations detailing the outcome measures on which these have been based, and give event rates, means and medians etc. as appropriate.
N.B. It is important to give the justification for the size of the difference that the trial is powered to detect. Does the sample size calculation take into account the anticipated rates of non-compliance and loss to follow-up given below?
2.12 What is the planned recruitment rate? How will the recruitment be organized? Over what time period will recruitment take place? What evidence is there that the planned recruitment rate is achievable?
2.13 Are there likely to be any problems with compliance? On what evidence are the compliance figures based?
2.14 What is the likely rate of loss to follow up? On what evidence is the loss to follow-up rate based?
2.15 How many centres will be involved?
2.16 What is the proposed type of analyses?
2.17 What is the proposed frequency of analyses?
2.18 Are there any planned subgroup analyses?
2.19 Has any pilot study been carried out using this design?
3. TRIAL MANAGEMENT
3.1 What are the arrangements for day to day management of the trial? E.g. Randomization, data handling, and who will be responsible for coordination.
3.2 What will be the role of each principal applicant and co-applicant proposed?
3.3 Describe the trial steering committee and if relevant the data safety and monitoring committee.
Guidelines on Appendices in RCT Applications
Applicants should note that the research proposal is limited to 13 pages, exclusive of references, tables, figures and diagrams, and should be a self-contained document. Elements central to a clear understanding of the proposal (e.g., design issues, analysis plans, primary assumptions of sample size calculations) should be included within the 13 pages. Appendices should be used judiciously, to provide important supplementary detail to the 13-page research proposal. A maximum of 35 pages may be submitted as appendices.
Appendix information should be limited only to information that reviewers may wish to consult on matters of detail (e.g., detailed calculations of sample size, ROC curves, sensitivity analyses). Widely accepted and validated surveys and questionnaires (e.g., SF-36, Beck Depression Score) need only be referred to in the protocol. If a new instrument is to be validated as part of a trial, or a previously validated instrument is to be used in a unique patient population, then it should be included. Less commonly used instruments should also be included as should consent forms and patient information sheets.
CIHR recognizes that some large, complex and/or multi-partnered submissions may require special circumstances with respect to the amount of documentation to be submitted. In these cases, the applicant should contact the RCT Unit at CIHR well in advance of the deadline date to discuss any special arrangements.
Evaluation of the Full Application
Listed below are key questions that will be taken into account when assessing each section of the application.
Section 1 - The need for a trial
Has the importance of the issue been adequately explained in terms of:
Section 2 - The proposed trial
Section 3 - Trial management
Other Important Issues
If you have any questions, please contact:
Canadian Institutes of Health Research
Room 97, 160 Elgin Street
Address locator: 4809A
Ottawa, Ontario K1A 0W9
Tel: (613) 957-6137, E-mail: ichikuru@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, or
Tel: (613) 941-4438, E-mail: tgasparini@cihr-irsc.gc.ca
Fax: (613) 954-1800
The applicant must ensure that the application package is complete. The application package will contain a copy of each module required by the program. It is not necessary to repeat the module if you are applying to more than one program requiring the same modules (e.g. CV Module). Simply copy the module(s) and append to the second application. However, if you are applying for more than one grant, you will have to modify the "Funds Held or Requested" for each application.
Please bind the original with elastic(s) or a bulldog clip. Please do not staple the original as certain pages are removed and used for administrative purposes rather than sending to peer reviewers.
The eight copies of the modules may be stapled, but they must be bound separately from the attachments. (Cerlox or spiral bindings are not permitted).
In an ongoing effort to evaluate the impact of its funded trials, CIHR has developed a SUMMARY FORM FOR APPROVED RANDOMIZED CONTROLLED TRIALS to the research module. Its aim is to capture a minimal amount of data on trial methodology, which will allow for the evaluation of the funded trials.
Once the trial has been approved, the Nominated Principal Investigator will receive the SUMMARY FORM by email, and is requested to complete and submit it to CIHR, quoting the assigned application number.
Canadian Institutes of Health Research
Room 97, 160 Elgin Street
Address locator: 4809A
Ottawa, Ontario K1A 0W9
Tel: (613) 957-6137, E-mail: ichikuru@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, or
Tel: (613) 941-4438, E-mail: tgasparini@cihr-irsc.gc.ca
Fax: (613) 954-1800
1 For definition of a systematic review, see Oxman AD. Checklist for review articles. BMJ 1994; 309:648-51.
