Instructions for Submission of Protocols for Retrospective Studies

Instructions for submission of a protocol for a retrospective study

Please submit the following documents:

The Regulatory Specialist will also add a linking log at the time of submission of the application to CPHS. This document correlates subject MRN to study subject ID and contains PHI.

Please note: The study PI/senior researcher on the team must maintain the linking log securely at all times during the course of the study and update info in this log as the study progresses.

Instructions for completion of protocol template for retrospective studies

  • Please fill out basic study data section. Always name Trinette Polydore, as the study coordinator
  • Please fill out the general and background information. Please provide at least 3 references within these two sections.
  • Please fill out the scientific sections – objectives, study design, study population, study procedures.
  • Example standard verbiage for some of the sections at the back end of the protocol are provided
  • The exact time period for the data that will be looked at for the study (say sept 2015 to Sept 2023) needs to be specified in the protocol.
  • Estimate the number of charts you will need to review – say 200, and specify in the protocol. It is preferable to slightly overestimate the number of charts you will need to review in order to obtain the data you need.

Data collection form

A separate study-specific excel sheet needs to be created wherein MRN/other PHI is replaced by the subject ID.

This is an excel sheet the study team should maintain for specific elements of the charts that they will be collecting data for (for example subject ID, height, weight, bp, etc.). Please provide the data collection sheet showing the specific data elements that will be collected for your project.

When you have the draft documents prepared, please send to:

Usha Menon ( ) and copy Trinette Polydore ( ) on the email.

Trinette will submit the IRB applications to both UT and/or MHH and/or LBJ though the iRIS or eProtocol software.