iRIS Implementation Task Force
Meeting Minutes:
- June 7, 2005 (Word)
- May 25, 2005 (PDF)
Subcommittee Assignments:
Implementation Timelines:
- iRIS Go Live Timeline (PowerPoint)
Workflow Documents:
- Workflow Diagrams (PDF)
NIH Clinical Research Training:
CCR Guidance and Forms:
- CCR Protocol Review Monitoring Committee (PRMC) Guidelines (PDF)
- CCR Protocol Template and Guidelines (PDF)
- CCR Informed Consent Checklist (PDF)
NIH Guidance and Forms:
- Guide to Preventing Conflicts of Interest in Human Research at NIH (January 2005) (PDF)
- OHSR Information Sheet #14: Guidance on the Research Use of Stored Samples or Data (PDF)
- M97-2 MAS: NIH Guidelines for Writing Research Protocols (PDF)
- NIH 88-23(a): Application to Use Radiation in Research Involving Human Subjects (PDF)
- NIH Guidelines for Using Recombinant DNA Molecules (April 2002) (PDF)
CTEP Guidance and Forms:
- CTEP Multi-Institute Guidelines (PDF)
- CTEP Letter of Intent (LOI) Policy (PDF)
- CTEP Protocol Submission Checklist (PDF)
CTEP - Phase I Templates:
- Phase I Single Agent Template (PDF)
- Phase I Combination Template (PDF)
- Phase I Organ Dysfunction - Renal Template (PDF)
- Phase I Organ Dysfunction - Hepatic Template (PDF)
CTEP - Phase II Templates:
FDA IND Guidance and Forms:
- FDA 21 CFR 312.60 - General Responsibilities of Investigators (PDF)
- FDA 21 CFR 312 Subpart B 312.20 - IND Exemptions (PDF)
- Summary of FDA Requirements for Investigators (PDF)
- Guidance for Industry - Phase I Studies (PDF)
- Exemptions for Studies of Lawfully Marketed Drug or Biologic Products for the Treatment of Cancer (Jan. 2004) (PDF)
- FDA 1571 IND: Submission Instructions (PDF)
- FDA 1571 IND: Application Form (PDF)
- FDA 1572 IND: Investigator Agreement (PDF)
IRB Guidance and Forms:
- NIH-1195: Clinical Research Protocol - Initial Application
- NIH-1195: DRAFT Initial Application 08-05 (PDF)
- IRB Protocol Submission Checklist (PDF)
- NIH-2702: Special Exemption from Research Protocol Form (PDF)
- Special Exception Follow-up Memo (PDF)
- Review of IRB Submission Action Table (PDF)
- Response to IRB Stipulations to Protocol Memo (PDF)
- Amendment Form (PDF)
- Amendment Approved w/o Stipulations or Recommendations Memo (PDF)
- Amendment Approved with Stipulations and Recommendations Memo (PDF)
- Amendment Approved w/o Stipulations But with Recommendations Memo (PDF)
- Amendment Stipulations Approved Memo (PDF)
- Final Approval Memo (PDF)
- Initial Expedited Approval Memo (PDF)
- Initial Review Approved with Recommendations Memo (PDF)
- Initial Review Approved with Stipulations and Recommendations Memo (PDF)
- Initial Review Deferred Memo (PDF)
- Initial Review Stipulations Approved Memo (PDF)
