Institute for Health Care Delivery Science

IIT Protocol Development and Review Process

The Biostatistics Design Workshop (BDW) is comprised of statisticians in the TCI-BSRF and provides a forum for statistical collaboration on the development, design, and analysis of interventional (I-IIT) protocols. All investigators are encouraged to contact the biostatistician early in the development stage of their protocol, so they can get advice on study design, data management, and appropriate statistical methods for analyzing endpoints. The time for development of the statistical sections for a protocol ranges between 2‐4 weeks depending on the readiness of the protocol and the engagement of the PI. Typically it takes 2 weeks to gather the information needed for writing the statistical sections, and then 1‐2 weeks for editing. The statistician assigned to your protocol will present it to the BDW once they have completed the statistical sections of the protocol. You do not need to submit or present to the BDW. Please be advised that an automated notification from the service requet form will be sent to the PI following the initial BDW review; this is for tracking purposes only. Statisticians will communicate progress to you and provide a final version of the protocol once it is approved.

Review Process for Interventional (I-IIT) Protocols:

Following are itemized steps of the BDW review process:

  1. All Interventional Investigator initiated research protocols must be reviewed by the Biostatistics Design Workshop (BDW) prior to submission to the DFG with exception for protocols that underwent scientific and biostatistical review by one of the following organizations.
  2. Collaborators should submit requests for statistical support for 'PROTOCOL DEVELOPMENT' through service request form
  3. DFG biostatistician is assigned and develops statistical sections of protocol
        1. Only Interventional (I-IIT) require BDW (DFG and PRMC) approval and need to contain the Essential Elements of a Protocol (industry provided protocol template), or be in proper PRMC format: Protocol Template
        2. The IRB format (HRP-503a) is NOT an acceptable format for I-IITs
  4. DFG Biostatistician submits protocol for BDW review when it is deemed ready by biostatistician and PI
  5. Once a protocol is approved by BDW, it can be presented at DFG
        1. On BDW approval, all track changes are accepted
        2. A version number and date of BDW approval is added to the protocol
        3. The BDW approved protocol is emailed to the PI, DFG Chairman and PRMC administrators
  6. After DFG approval, the protocol can be submitted for PRMC review (contact Venesha White for information on this submission process)

Protocol Related Information and Guidelines