IDI REC Forms IDI REC Home IDI REC members’ Profiles IDI REC Standard Operating Procedures (SOPs) Forms Form 3.1 C IDI REC Submission Checklist Form 3.1 B study Summary Form Form 3.2 Claim of Exemption Form 3.5 A Study Folder Contenet Checklist Form 3.6 Archiving Precedure Checklist Form 4.1 A Determination of qualification for Expedited Review Form 4.1 B Guidance Expedited Review Form 4.1 C Expedited Review- Reviewer Materials Checklist Form 4.3 D Serous Adverse Event Report Form 4.3 E Adverse Event Report Review Form FORM 4.3 G Amendment Submission Form Form 4.4 A Continuing Review Report- Renewal request Form 5.1 A Checklist-Requirements for Involving Prisoners Form 5.1 C Checklist- Requirements involving Pregnant women and Fetuses Form 5.1 Checklist-Requirements for involving Children Form 5.1 D Checklist-Requirements for Research Involving Handcapped Participants Form 5.2 A Risk Determination -Devices Form 5.2 B Reporting Emergency use of Test Device Form 5.2 C Report of Emergency use of Test Article to treat a life -threatening conditions Form 5.2 D Checklist-Emergency Research conducted under exemption from informed consent Requirements Form 5.2 E Waiver of Informed Consent for Access to Medical records for Research Form 7.1 E Checklist for Assessing the Adequacy of the Inromed Consent Form for Genetic studies Form 7.1 F Template for Informed Consent Form for Genetic Studies Form 7.1A- Informed Consent Checklist Form 7.1 B Informed Consent Document Template Form 7.1 C Checklist to Assess the Adequacy of Informed Consent Forms Form 7.1 D Informed Consent Document Template-Tissue-Blood Storage for Future use Form 7.1 G Informed Consent Document Template- Venipuncture Form 7.2 A Waiver or Alteration of Informed Consent Decision Chart Form 7.3 C Parental Consent Form Form 7.3 A Requirements Checklist for Consent-assent of Minors Form 8.1 A Investigator Responsibilities IDI REC Requirements Form 8.1 B Essential Documents Form 8.1 B Serious Adverse Report Form Form 8.2 A Sponsor Responsibilities