Sync template from atomicqms-style deployment

Forms/Submissions/FRM-IRB-001-Protocol-Submission-Form.md

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+# IRB Protocol Submission Form
+
+| Form ID | FRM-IRB-001 | Revision | 1.0 |
+|---------|-------------|----------|-----|
+
+---
+
+## Section 1: General Information
+
+### 1.1 Submission Type
+
+☐ New Protocol
+☐ Modification/Amendment to Protocol #: _____________
+☐ Continuing Review for Protocol #: _____________
+
+### 1.2 Study Identification
+
+| Field | Entry |
+|-------|-------|
+| Protocol Title | |
+| Short Title (≤50 characters) | |
+| Proposed Start Date | |
+| Expected Duration | months |
+
+### 1.3 Review Category Requested
+
+☐ Exempt (specify category): _____________
+☐ Expedited (specify category): _____________
+☐ Full Board Review
+
+---
+
+## Section 2: Principal Investigator Information
+
+| Field | Entry |
+|-------|-------|
+| Name | |
+| Title/Position | |
+| Department | |
+| Institution | |
+| Mailing Address | |
+| Phone | |
+| Email | |
+| Faculty Sponsor (if PI is student) | |
+
+**Training Certification:**
+| Certification | Expiration Date |
+|---------------|-----------------|
+| CITI Human Subjects | |
+| GCP (if applicable) | |
+| Other: | |
+
+---
+
+## Section 3: Research Team
+
+| Name | Role | Department | Training Current? |
+|------|------|------------|-------------------|
+| | PI | | ☐ Yes |
+| | | | ☐ Yes |
+| | | | ☐ Yes |
+| | | | ☐ Yes |
+| | | | ☐ Yes |
+
+---
+
+## Section 4: Funding Information
+
+### 4.1 Funding Source
+
+☐ Internally Funded (Department/Institution)
+☐ Federal Grant (Agency: _____________)
+☐ Industry Sponsored (Sponsor: _____________)
+☐ Foundation/Non-Profit (Name: _____________)
+☐ Not Funded
+
+### 4.2 Grant Information (if applicable)
+
+| Field | Entry |
+|-------|-------|
+| Grant/Contract Number | |
+| Funding Period | |
+| Grant Title | |
+
+---
+
+## Section 5: Study Overview
+
+### 5.1 Purpose and Objectives
+
+*Briefly describe the purpose of this research and specific aims (250 words max):*
+
+### 5.2 Background and Rationale
+
+*Provide scientific background and justification (500 words max):*
+
+### 5.3 Research Design
+
+☐ Observational/Non-interventional
+☐ Interventional
+☐ Clinical Trial
+☐ Survey/Questionnaire
+☐ Interview/Focus Group
+☐ Secondary Data Analysis
+☐ Other: _____________
+
+---
+
+## Section 6: Subject Population
+
+### 6.1 Target Population
+
+| Field | Entry |
+|-------|-------|
+| Minimum Age | |
+| Maximum Age | |
+| Target Enrollment (this site) | |
+| Target Enrollment (total, all sites) | |
+
+### 6.2 Inclusion Criteria
+
+*List specific inclusion criteria:*
+
+1.
+2.
+3.
+4.
+5.
+
+### 6.3 Exclusion Criteria
+
+*List specific exclusion criteria:*
+
+1.
+2.
+3.
+4.
+5.
+
+### 6.4 Vulnerable Populations
+
+*Check all that may be included:*
+
+☐ None
+☐ Children/Minors
+☐ Prisoners
+☐ Pregnant Women
+☐ Cognitively Impaired
+☐ Economically Disadvantaged
+☐ Educationally Disadvantaged
+☐ Students of PI
+☐ Employees of PI
+☐ Decisionally Impaired
+☐ Other: _____________
+
+*If vulnerable populations included, describe additional protections:*
+
+---
+
+## Section 7: Recruitment
+
+### 7.1 Recruitment Methods
+
+*Check all that apply:*
+
+☐ Medical records review
+☐ Advertising (print, radio, TV)
+☐ Internet/Social media
+☐ Flyers/Posters
+☐ Direct approach in clinic
+☐ Telephone
+☐ Email
+☐ Referral from provider
+☐ Community outreach
+☐ Other: _____________
+
+### 7.2 Recruitment Materials
+
+*List all recruitment materials attached:*
+
+| Document Name | Version/Date |
+|---------------|--------------|
+| | |
+| | |
+| | |
+
+---
+
+## Section 8: Research Procedures
+
+### 8.1 Study Procedures
+
+*Describe all procedures subjects will undergo (include timeline):*
+
+### 8.2 Duration of Participation
+
+| Field | Entry |
+|-------|-------|
+| Number of visits | |
+| Duration of each visit | |
+| Total participation time | |
+| Follow-up duration | |
+
+### 8.3 Study Location(s)
+
+| Location | Address |
+|----------|---------|
+| | |
+| | |
+
+---
+
+## Section 9: Drugs, Devices, and Biologics
+
+### 9.1 Does this study involve drugs, devices, or biologics?
+
+☐ No → Skip to Section 10
+☐ Yes → Complete below
+
+### 9.2 Drug Information
+
+| Field | Entry |
+|-------|-------|
+| Drug Name | |
+| IND Number (or Exemption) | |
+| FDA Approval Status | ☐ Approved ☐ Investigational |
+| IND Sponsor | |
+
+### 9.3 Device Information
+
+| Field | Entry |
+|-------|-------|
+| Device Name | |
+| IDE Number (or Exemption) | |
+| FDA Approval Status | ☐ Approved ☐ Investigational ☐ Exempt |
+| Device Risk | ☐ Significant Risk ☐ Non-Significant Risk |
+
+---
+
+## Section 10: Risks and Benefits
+
+### 10.1 Risks
+
+*Describe all foreseeable risks (physical, psychological, social, economic, legal):*
+
+| Risk | Likelihood | Severity | Mitigation |
+|------|------------|----------|------------|
+| | ☐ Low ☐ Med ☐ High | ☐ Low ☐ Med ☐ High | |
+| | ☐ Low ☐ Med ☐ High | ☐ Low ☐ Med ☐ High | |
+| | ☐ Low ☐ Med ☐ High | ☐ Low ☐ Med ☐ High | |
+
+### 10.2 Benefits
+
+*Describe potential benefits:*
+
+**To subjects:**
+
+**To others/society:**
+
+### 10.3 Risk/Benefit Assessment
+
+*Justify why risks are reasonable in relation to anticipated benefits:*
+
+---
+
+## Section 11: Privacy and Confidentiality
+
+### 11.1 Identifiable Information Collected
+
+*Check all that apply:*
+
+☐ Name
+☐ Date of birth
+☐ Social Security Number
+☐ Medical Record Number
+☐ Address
+☐ Phone number
+☐ Email
+☐ Photographs/Video
+☐ Audio recordings
+☐ IP address
+☐ Genetic information
+☐ Other: _____________
+
+### 11.2 Data Storage and Security
+
+| Field | Entry |
+|-------|-------|
+| Storage location | ☐ Paper ☐ Electronic ☐ Both |
+| Physical security measures | |
+| Electronic security measures | |
+| Who will have access to data? | |
+| Data retention period | |
+| Disposition after study | ☐ Destroy ☐ Archive |
+
+### 11.3 Data Sharing
+
+Will data be shared with others outside the research team?
+☐ No ☐ Yes (describe): _____________
+
+---
+
+## Section 12: Informed Consent
+
+### 12.1 Consent Process
+
+*Describe how consent will be obtained:*
+
+☐ Written consent from subject
+☐ Written consent from LAR
+☐ Oral consent with documentation
+☐ Waiver of documentation of consent
+☐ Waiver of consent
+
+### 12.2 Consent Documents
+
+| Document | Language | Version/Date |
+|----------|----------|--------------|
+| Consent Form | | |
+| Consent Form | | |
+| Assent Form | | |
+| HIPAA Authorization | | |
+
+### 12.3 Waivers Requested
+
+**Waiver of Consent (45 CFR 46.116(f)):**
+☐ Not requested
+☐ Requested - Justify below:
+
+**Waiver of Documentation of Consent (45 CFR 46.117(c)):**
+☐ Not requested
+☐ Requested - Justify below:
+
+**Waiver of HIPAA Authorization (45 CFR 164.512(i)):**
+☐ Not requested
+☐ Requested - Justify below:
+
+---
+
+## Section 13: Compensation
+
+### 13.1 Subject Compensation
+
+☐ No compensation
+☐ Yes → Complete below
+
+| Visit/Activity | Compensation Amount |
+|----------------|---------------------|
+| | $ |
+| | $ |
+| Total possible | $ |
+
+### 13.2 Payment Method
+
+☐ Cash ☐ Check ☐ Gift card ☐ Other: _____________
+
+---
+
+## Section 14: Conflict of Interest
+
+### 14.1 Financial Interests
+
+Does any member of the research team have a financial interest in the study sponsor, product, or outcome?
+
+☐ No
+☐ Yes (disclosure attached)
+
+---
+
+## Section 15: Required Attachments Checklist
+
+| Document | Attached? |
+|----------|-----------|
+| Research Protocol | ☐ |
+| Informed Consent Form(s) | ☐ |
+| Assent Form(s) | ☐ or N/A |
+| HIPAA Authorization | ☐ or N/A |
+| Recruitment Materials | ☐ or N/A |
+| Surveys/Questionnaires | ☐ or N/A |
+| Training Certificates | ☐ |
+| COI Disclosures | ☐ |
+| Grant/Funding Documents | ☐ or N/A |
+| Investigator Brochure | ☐ or N/A |
+| Site Authorization Letters | ☐ or N/A |
+| Data Use Agreement | ☐ or N/A |
+| Other: _____________ | ☐ |
+
+---
+
+## Section 16: PI Assurance
+
+By signing below, I certify that:
+
+- I have read and will comply with all institutional policies and federal regulations
+- All information in this application is accurate and complete
+- I will obtain IRB approval before initiating any changes
+- I will report adverse events and unanticipated problems promptly
+- I will ensure all study personnel are appropriately trained
+- I take responsibility for the conduct of this research
+
+| Field | Entry |
+|-------|-------|
+| PI Signature | |
+| Date | |
+
+---
+
+## Section 17: Department Approval (if required)
+
+| Field | Entry |
+|-------|-------|
+| Department Chair/Designee | |
+| Signature | |
+| Date | |
+
+---
+
+## For IRB Use Only
+
+| Field | Entry |
+|-------|-------|
+| Date Received | |
+| IRB Protocol Number | |
+| Review Category Assigned | ☐ Exempt ☐ Expedited ☐ Full Board |
+| Primary Reviewer | |
+| Secondary Reviewer | |
+| Meeting Date (if Full Board) | |
+| Action | |
+| Approval Date | |
+| Expiration Date | |
+
+---
+
+*Form FRM-IRB-001 Rev 1.0 - IRB Protocol Submission Form*