Study Activation Form

The Study Activation Form (SAF) collects basic information needed by the Clinical Trial Research Management Group (CT RMG).  The SAF is one of the required Minimum Documents that a study team completes and submits to CT RMG’s Intake Team. The SAF facilitates:

  • the set-up of an Industry-Sponsored Clinical Trial in SeRA and generation of a SPO number
  • assignment of Clinical Trial Research Process Manager (CT RPM) and Clinical Trial Contract Officer (CT CO)
  • development of the budget
  • contract review
  • request for a Kickoff Meeting

Please HOLD submission of study documents to CT RMG’s Intake Team until all information is available, including a complete SAF. For questions about the SAF, please reach out to your department’s assigned CT RPM or CT CO.

How to complete CT RMG SAF

The study team should download and complete the fillable PDF SAF form to initiate the budget and contract processes. To streamline the study start up process, please HOLD submission of Minimum Documents until all information is available to fully complete the SAF.

For expedited study start up process, complete the SAF after IRB submission.

Basic study details required to complete the SAF includes:

  • study type (e.g., drug, device, PI-initiated)
  • study team and sponsor contact information
  • status of IRB submission
  • study timeline, such as start date
  • information about device, if applicable
  • budget information (e.g., number of patients, study location, start-up costs, effort estimates)

If you have questions on how to complete the Effort Estimate section of the SAF, please reach out to your department’s CT RPM and/or consider attending Spectrum’s training session:  Research Budgeting and the Workbook Process.

Your assigned CT RPM may reach out to the study team prior to the Kickoff Meeting if additional clarification is required on information provided on SAF.