5) Post Activation Forms

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 (ie. 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 6/2006 template. Outdated versions will not be accepted. 

• DFCI Protocol Front Sheet *REVISED*
  • Guidance on Completing Protocol Front Sheet
• Amendment Form *REVISED*
• New!  Alert Page Template
  • Guidance on Alert Pages
• PI/Site PI Change Form *REVISED*
• Research Team Update Form *REVISED*
• Request to Add/Remove a Site Form
• Serious Adverse Event (SAE) Reporting Form
• Adverse Event Reporting Guidelines
• IND Safety Reporting Form
• Protocol Deviation Report Form *REVISED*
• Protocol Deviation Log  *REVISED*
• Closure/Re-Open to Accrual Form
• Priority List Placement Change Form *REVISED*

Link to QACT Forms, which include:
Forms for registering or removing a subject to/from a protocol,
escalating to the next dose cohort,
requesting data from your PI-initiated protocol,
providing information to the DSMC or DSMB, and
looking up toxicity codes.

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  • Office for Human Research Studies (OHRS)
    • Contacts
    • Information for Sponsors
    • Submitting A New Protocol
    • Consent Documents
    • After Activation Forms
    • HIPAA
    • OHRS Information Sheets
    • External Regulatory Guidance
    • OHRS News Updates
    • Oncology Protocol System and OHRS Submit
    • Presentation and Training Materials
    • Partners Policy and Guidance Links
  • Quality Assurance Office for Clinical Trials (QACT)
  • Clinical Research Unit (CRU)
  • Clinical Trials Education Office (CTEO)
  • Protocol Review and Monitoring System (PRMS)
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