Forms & Templates
Help Build Your Protocol and Submit Your Study
The forms and templates provided on this page will help you build your protocol and submit your study to Baystate's Human Protection Program for review.
Application Forms
B01 - Application - Human Subjects Research Determination
B01.1 - Application Checklist - Human Subjects Research Determination
B02 - Application - Request for Determination of Exemption
B02.1 - Application Checklist - Request for Determination of Exemption
B03 - Application - Basic Part 2
B03.1 - Application Checklist - Investigator Initiated New Projects
B03.2 - Application Checklist - Sponsor Initiated New Projects
B03.3 - Application - Local Context Supplement
B04 - Application - Ancillary Services and Additional Approvals
B05 - Application - Pathology Services
B06 - Application - Conflict of Interest and Commitment Questionnaire
B07 - Application - Continuing Review Report
B08 - Application - Continuing Review for NCI CIRB
B09 - Application - Continuing Review Report for HUDs
B10 - Application - Research Status Report
B11 - Application - Study Closure Report
B12 - Application - Administrative Report Form
B13 - Application - Event Reporting Form
B14 - Application - Modification Request (Amendment)
B16 - Application - Emergency Use Report
B17 - Application - Humanitarian Use Devices (HUD)
B18 - Application - Preparatory to Research
B19 - Application - Clinical Trials Service Request
B20 - Application - MA DPH Controlled Substance Researcher
B23 - Application - Clinical Trial Directory Form
Research Involving PHI of Deceased Individuals Attestation Form
Supplemental Materials
B22.1 - Supplemental - A-D- Vulnerable Populations
B22.2 - Supplemental - E - G - Request for Waivers of Consent and HIPAA
B22.3 - Supplemental - H-I- Data Security & Confidentiality
Forms H & I Email Job Aid
B22.4 - Supplemental - K-O- Other Considerations
B22.5 - Supplemental - R1-R4 - Vulnerable Populations for External Reliance
Protocol & Consent Templates
C01 - Template - Protocol (Experimental Design)
C02 - Template - Protocol (Non-Experimental Design)
C03 - Template - Consent Form (Clinical Trial)
C03.1 - Template - Consent Rider for Pediatric Assent
C03.2 - Template - Consent Rider for Continuing Consent
C03.3 - Template - Consent Rider for Future Research Including Banking of Information & Specimens
C03.4 - Template - Consent Rider for Genetic Testing
C03.5 - Template - Consent Rider for HIV Testing
C03.6 - Template - Consent Rider for Sub-Studies and Corollary Studies
C05 - Template - Consent Form (Information Sheets or Scripts - Waiver of ICF)
C06 - Template - Consent Form (Pregnant Partner)
C07 - Template - Consent Form (Psychotherapy Notes Authorization)
Resources
Consent of Elements Comparison
COVID-19 Impact Statement HRPP/IRB
Initiating Remote Access to CIS - SARF - Non-employee
Requirements for Waiver of Alteration Flow Chart
Requirements for Waiver and Alteration of Consent PowerPoint
Instructions for Obtaining CE Credit
Checklists
QI versus Clinical Research Checklist
Supplemental Form Guides
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