The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Clinical Trial Planning Milestone Checklist

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September 29, 2016

To be completed by the applicant

Title of study:
Principal Investigator:
Applicant Contact: EmailPhone
Form completed by:
Does the Applicant have a Prior NIAMS funded R34 or U34 (yes/no)?If yes, please indicate grant number
Proposed date of submission of the U01 application (see deadlines below):

Note: If the budget is $500,000 or greater in direct costs in any given year, a separate Letter of Request (LOR) must be submitted by the appropriate deadline (10 weeks prior to the application due date). No exceptions.

Proposed Clinical Trial Budget (total costs all years — direct and indirect costs):

Proposed Direct Costs only per Year:

Year 1: Year 2: Year 3: Year 4: Year 5:

Due dates for a U01 application, and Letters of Request (for applications with budgets of $500,000 or greater in direct costs in any given year)

U01 Application Due Date Letter of Request (LOR) Due Date (required 10 weeks prior to the application due date)
March 1, 2017 December 28, 2016
July 3, 2017 April 24, 2017
November 1, 2017 August 23, 2017
March 2, 2018 December 22, 2017
July 2, 2018 April 23, 2018
November 1, 2018 August 23, 2018
March 1, 2019 December 22, 2018
July 1, 2019 April 22, 2019
November 1, 2019 August 23, 2019


Instructions: The applicant should indicate a status by marking an "X" under the appropriate status heading for each planning activity with additional comment (s) to justify any item(s) that are not complete at the time the checklist is submitted to the NIAMS.

Planning Activity Status


(please include additional detail regarding the status of the activity including any anticipated dates of completion if the activity is not yet complete)
NIAMS Internal Use Only
Completed In process Not started Not applicable
Clinical study protocol            
Budget proposal for U01 application            
Identification and qualifications of clinical trial sites, pharmacies and laboratories            
Investigator Brochure (IB) or equivalent            
Data and safety monitoring plan            
Finalize plans to obtain intervention related products (drugs, placebo, device)            
Develop Clinical Trial Agreement (CTA) and/or Cooperative Research and Development Agreement (CRADA)            
Develop template informed consent (and assent form, if applicable)            
Develop case report forms (CRFs)            
Program database            
Establish data collection system for primary and/or remote sites            
Submit/obtain approval for IND/IDE or exemption            
Develop and plan materials for training and site initiation            
Initiate IRB approval including plans for s-IRB/reliance agreements            
Documentation of adequate co-funding, if applicable and necessary for completion of the trial            

NIAMS Staff Comments (internal use only):