Resources
Listed below are links to FDA websites:
Listed below are links to Emory-specific forms and tools to assist with study conduct:
We collaborated with the Emory Institutional Review Board and the Clinical Trials Audit and Compliance (CTAC) department to develop these shared, Emory University tools for clinical trials. These are optional templates only. Feel free to modify them to meet the needs of your department or trial.
- Adverse Event Log (DOCX)
- Corrective and Preventive Action Worksheet (DOCX)
- Concomitant Medication Log (DOCX)
- Delegation of Authority Log (DOCX)
- Device Accountability Log (DOCX)
- Eligibility Criteria Checklist (DOC)
- Enrollment Log (DOC)
- Informed Consent Form Version Tracking Log (EXCEL)
- Informed Consent Process Note (DOC)
- Informed Consent Process Note Stickers (DOC)
- Informed Consent Tracking Log by Subject (EXCEL)
- Meeting Minutes Template (DOC)
- Monitoring Log (DOCX)
- Note to File Template (DOCX)
- Out of Range Stickers (DOCX)
- Phone Screening Log (DOC)
- Protocol Deviation Log (DOC)
- Regulatory Documentation Checklist (DOC)
- Retained Fluid and Tissue Log (DOCX)
- Screening Log (DOCX)
- Signature Sheet (DOC)
- Single Visit Checklist (DOCX)
- Study Closeout Checklist (DOCX)
- Study Personnel Training Checklist (DOCX)
- Study-Specific Signature Log (DOC)
- Study-Specific Training Log (DOCX)
- Study Startup Checklist (DOCX)
- Study Team Modifications (DOC)
- Study Visit Checklist (DOC)
- Subject Compensation Log (DOCX)
- Subject Schedule by Enrollment (EXCEL)
- Telephone Contact Note (DOCX)
- Training Attendance Log (DOCX)
FDA guidance documents represent FDA's current thinking on a topic and provide information on how regulations should be met for a particular subject. All FDA Guidance Documents
- Electronic Source Data in Clinical Investigations (PDF)
- FAQs on Form 1572 (PDF)
- Good Clinical Practice: ICH E6 (R2) (PDF)
- IND Determination (PDF)
- Investigator Responsibilities (PDF)
- IRB Continuing Review After Clinical Investigation Approval (PDF)
- IRB Responsibilities for Reviewing the Qualifications of Investigators, Research Sites, and the Determination of Whether an IND/IDE is Needed (PDF)
- FDA Decisions for IDE Clinical Investigations (PDF)
- Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators
- Guidance for Industry: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers (fda.gov)
- Software as a Medical Device(SaMD)