Conduct Forms and Templates

Conduct of all DF/HCC clinical trials must follow all DF/HCC Standard Operating Procedures (SOPs). The Office of Human Research Studies (OHRS) and The Office of Data Quality (ODQ) have created numerous Guidances and Information Sheets to assist researchers in the management of their studies. ODQ also offers data management services for PI-initiated studies. Serious Adverse Event Reporting and Continuing Review requirements are essential elements of trial conduct. The Clinical Operations Committee (CLINOPS) provides a forum for research management at the DF/HCC member institutions.

This section provides information and required forms and templates associated with protocol conduct.

Ongoing Research (After Initial Submission) Forms

You are responsible for using the most current version of our IRB forms posted on this website. If you do not, and outdated forms are submitted to OHRS, it is possible that the submission will not be processed or reviewed by the SRC and/or IRB. Please make sure to ALWAYS download forms directly from this website. Forms downloaded to your computer will not be the most recent version and will delay review. Opening forms directly from the OHRS website before filling them out and submitting them to us will assure you have the most up-to-date form and will save both you and the OHRS time. 

A revised front sheet MUST be submitted with the following revisions: Amendment, PI/Site PI Change, Research Team Update, Request to Add New Site IF the revision changes the information captured on the front sheet (i.e., protocol name, protocol version date, type of trial, principal investigator, site principal investigator, collaborating investigators, study contacts, participating sites, and subject population). All revised front sheets must be on the most current template. Outdated versions will not be accepted.

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