This form is for use by the Principal Investigator when seeking institutional sponsorship by their institution. It is to be used in conjunction with the Institutional Sponsorship Application and Approval for Sponsor-Investigator Initiated Trials SOP.
The Principal Investigator is required to complete the form and associated risk management plan that is pre-populated with ten risk categories applicable to most trials. The table requires the Principal Investigator to enter the following information for each risk identified within the ten categories: consequence, likelihood, mitigation strategy, risk monitoring plan.
The form is then submitted with the latest draft of the protocol to the sponsorship committee for consideration. Further details about the sponsorship review and approval process are found in the SOP Institutional Sponsorship Application and Approval for Sponsor-Investigator Initiated Trials
