Proposals will only be considered if at least one author is a registered full or associate member of the consortium.  The PI’s institution should be a PIRRC Institutional Member or they must apply for enrolment.

Submission Process:

Letter of Intent:

  • Author submits a letter of intent (standardized template:  Brief outline in lay terms, projected sample size, study related interventions statistician information, expected study timeline, funding available, etc).
  • LOI reviewed at monthly BOD/Committee Meeting.  PI will be notified of decision to request submission of a protocol.

Protocol Submission:

If protocol submission is requested, the PI will submit a proposal that includes (but is not limited to):

  • Background
  • Objectives
  • Hypothesis
  • Materials / Methods
    • Section of protection of personal health information (to be standardized by consortia and included in every protocol)
  • Budget
  • Statistical Analysis
  • Data Forms
  • Case Report Forms
  • Consent Forms
  • AE/SAE Report Forms
  • Any relevant addendums 
  • If already approved at local site, copy of ethics board submission

NOTE: All proposals for prospective studies must have been reviewed by a statistician prior to submission to the consortium board to ensure feasibility and significance of study design

Evaluation of Proposal:

The BOD/Committee will review the proposal at their next meeting.

  • If the protocol is accepted without changes, a formal, standardized, approval letter will be sent to the new Principal Investigator (PI) outlining the process going forward – please see section titled RESPONSIBILITIES OF A LEAD SITE
  • If the board requires clarification/modifications to the proposal, the board will assign a board-member as the lead reviewer whose responsibilities involve liaising with the author and the review board and communicating potential changes to the proposal and final acceptance/denial of the protocol.  If after revisions, a protocol is accepted, the above mentioned letter of approval will be sent to the author.
  • If the protocol is declined, a standardized unapproved protocol letter will be sent.  If the protocol is declined due to PIRRC capacity issues, efforts will be made to help support development of the study outside of PIRRC oversight.