Human Subject Forms

Please note that forms listed below are to be printed and manually completed.

TITLE	DESCRIPTION	SOPs
Adverse Events Documentation Form	Data collection for AEs
Attestation for the Use of Devices	Required R&D form for devices	06.01
Attestation for the Use of Equipment in the Conduct of a Research Study	Required R&D form for equipment	06.01
Attestation for the Performance of Procedures in the Conduct of a Research Study	Required R&D form for performing procedures	06.01
Audit Notification Letter Template (not available online)	ORC form for audits	02.02 02.03
Chart Audit Log (not available online)	ORC form for auditors	02.03
Clinic Names	List of Research Clinics
Clinical Research Hazards Screening Form DISCONTINUED
Clinical Trials Data Sheet	Required form for R&D submission	01.03 01.04 05.01
Clinical Trials Standards	Guide for auditors and investigators/staff	07.02G
Clinical Warning Algorithm (not available online)	Decision process for writing a Research Subject Clinical Warning in CPRS	07.01
Clinical Warning Template	Guide for writing a Research Subject Clinical Warning in CPRS	07.01
Complaint Information Form	Intake form when a complaint or allegation of noncompliance is received	01.07
Confirmation of Required Trainings of Research Staff	Tool for investigators/staff Validates staff training is current
Cover Letter for Scanning Informed Consent Form	Required form when submitting ICFs for scanning	07.01
CRF-DCF Template	Suggested way to adapt forms for data collection	07.03G
Data Security Checklist for Research Protocols	Required for R&D submission	01.12 01.13
Determination of Sample Size for Random Audit (not available online)	Guide for ORC auditors	02.02 02.03
Elements of Informed Consent – Appendix C of VHA Handbook	Guide for writing an ICF	03.01G 03.02
Enrollment Note Algorithm (not available online)	Decision process for writing an enrollment note in CPRS	07.01
Enrollment Note Template	Guide for writing an enrollment note in CPRS	07.01
Guidelines for Internal Source Documents Audit (not available online)	Tool for ORC auditors	02.03
Guidelines for Narrative Notes	Tool for research staff	07.03G
Guidelines for Time-Event Sheets	Tool for research staff	07.02G 07.03G
HRPP Implementation Flowchart (not available online)	Organizational Chart	01.02
HRPP Organizational Chart (not available online)	Organizational Chart	01.02
Informed Consent Process Worksheet	Tool for research staff: documenting the IC process	07.03G
Investigational Device Accountability Log	Tool for investigators	06.01
Investigational Drug Information Record (VA Form 10-9012)	Required for R&D submission; can be used for the RCSW	05.01
Investigational Pharmacy Drug Log (not available online)	Form used by the VAMHCS investigational pharmacy	05.01
Lay Language for Informed Consent	Tool for investigators/staff	03.01G
Outpatient Clinic Profile DISCONTINUED	Required for R&D submission	01.03 01.04
Pharmacy Audit-A-Companion Tool (not available online)	Tool for ORC auditors	02.05
Pharmacy Audit-A-Investigational Drug Dispensing Tool (not available online)	ORC form for audits	02.05
Pharmacy Audit-B-Companion Tool (not available)	Tool for ORC auditors	02.05
Pharmacy Audit-B-Investigational Drug Log Tool (not available online)	ORC form for audits	02.05
Pharmacy Audit-C-Report Summary (not available online)	ORC form for audits	02.05
Pharmacy Audit-Study Subject Worksheet (not available online)	ORC form for audits	02.05
Pharmacy Fee Forms (not available online)	Required for R&D submission; obtain from the Investigational Drug Pharmacist	01.03 01.04 05.01
Pre-Study Assignments – Sponsor	Tool for investigators/staff
Pre-Study Assignments – Staff	Tool for investigators/staff
Problem Resolution Worksheet DISCONTINUED	Tool for internal audits	02.02 02.03
QA Audit Tool – Summary Checklists for Regulatory and Source Documents (not available online)	Collects and summarizes audit findings	02.02 02.03
QA Pre-Audit Interview Checklist (not available online)	Guide for pre-audit meetings with PI and staff	02.02 02.03
QA Module A – Staff Requirements (not available online)	Tool to document research staff mandatory training requirements	02.02 02.03
QA Module B – Entry Criteria (individual subjects) (not available online)	Tool to document whether research subjects were entered properly and whether there is source documentation	02.02 02.03
QA Module C – Lab Inclusion-Exclusion (not available online)	Tool to document lab data	02.02 02.03
QA Module D – Elements of ICF (not available online)	Tool to evaluate ICFs	02.02 02.03
QA Module E – Execution of ICF (not available online)	Tool to evaluate signatures and ICF versions	02.02 02.03
QA Module F – Informed Consent Process (not available online)	Tool to evaluate the process and documentation	02.02 02.03
QA Module G – Source Documents Audit (not available online)	Tool for source documents audit	02.02 02.03
QA Module H – Research Procedures (not available online)	Tool to evaluate documentation of research procedures	02.02 02.03
QA Module I – Unanticipated events (AEs) (not available online)	Tool to evaluate documentation of UEs/AEs	02.02 02.03
Regulatory Timeline	Can be used as a guide/table of contents for regulatory documents
Request for Corrections to ICFs for Scanning	Required form when submitting corrections to scanned ICFs	07.01
Research Documents that are Subject to Audits by the ORC	Tool for investigators/staff	02.01 02.02 02.03
Research Methods Accountability Forms (RMAF) DISCONTINUED	Required for R&D submission	01.03 01.04 05.01
Research Protocol Safety Survey (RPSS) (VA Form 10-0398)	Required for R&D submission
RPSS Instruction Memo	Instructions to assist with completion of the RPSS
RPSS Radioactive Materials (Appendix A)	Required if the study involves radioactive materials
Sample Credentialing or Training Logs	Tool for investigators/staff	06.01
Sample Time-Event Sheets	Tool for investigators/staff	07.05G
Self Assessments – Investigator Records Checklist	Tool for investigators/staff	02.01 02.04
Self Assessments – Informed Consent Form Review DISCONTINUED	Tool for investigators/staff	02.01 02.04
Self Assessments – Investigator Interview Checklist	Tool for investigators/staff	02.01 02.04
Self Assessments – Subject Records Checklist	Tool for investigators/staff	02.01 02.04
SOP Template	Tool for investigators/staff	07.05G
Source Documents Audit	Tool for internal audits	02.03
SRS Annual Review & Amendments of Research Protocols	Required for Subcommittee on Research Safety (SRS) annual review or submission of amendments
Tests of Understanding and Decisional Capacity	Tool for investigators/staff	03.01G
VA Form 10-9012, Investigational Drug Information Record		01.03 01.04 05.01
VA Form 10-1086, Research Consent Form		03.01G 03.02
VA Trainings ("How-To Guide for LMS Users")	Tool for investigators/staff
Worksheet for Submissions to R&D Committee (Human Studies)	Required for R&D submission	01.03 01.04

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