[Project Name] - INT

1. Awards-Agrmts-Finance (AAF)

1.1. Agrmts

1.1.1. [Partner Name] - COPY ME

1.1.1.1. [Agrmt or Amd Name] - COPY ME

1.1.1.1.1. CoJusts

1.1.1.1.2. Drafts

1.1.1.1.3. Proposals

1.1.1.2. Rpts

1.1.1.2.1. Audit Rpts

1.1.1.2.2. Fin Rpts & Invs

1.1.1.2.3. Tech Rpts

1.1.1.3. Proposals

1.1.2. Templates

1.2. Awards

1.2.1. [Donor Name]-[AWD-#] - COPY ME

1.2.1.1. Award Docs

1.2.1.2. Budget

1.2.1.3. Proposals

1.2.1.4. Rpts

1.3. Intellectual Property

1.4. RFPs

1.4.1. [RFP Short Name] - COPY ME

2. Clinical (Clin)

2.1. [Phase]-[Study Number] - COPY ME

2.1.1. [Partner Name] - COPY ME

2.1.1.1. CVs Qualifications

2.1.1.2. Note-Mtgs-Comms

2.1.1.3. Presentations

2.1.2. Central & Local Testing

2.1.2.1. Facility Docs

2.1.2.2. Notes Meetings Comms

2.1.2.3. Sample Docs

2.1.3. Central Trial

2.1.3.1. Notes-Mtgs-Comms

2.1.3.2. Rpts

2.1.3.3. Template Subj Materials

2.1.3.4. Trial Docs

2.1.4. Data Mgmt

2.1.4.1. Data Capture

2.1.4.2. Database

2.1.4.3. Notes-Mtgs-Comms

2.1.4.4. Oversight

2.1.4.5. EXT Data Transfer Specs

2.1.5. IP & Trial Supplies

2.1.5.1. Allocation

2.1.5.2. General

2.1.5.3. Notes-Mtgs-Comms

2.1.5.4. Release Process

2.1.5.5. Storage

2.1.5.6. Trial Supplies

2.1.6. IRB [Number]-[NAME OF IRB] - COPY ME

2.1.6.1. Non-Submission Comms

2.1.6.2. Other Submissions

2.1.6.3. Submissions Approvals

2.1.7. Safety

2.1.7.1. Notes Meetings Comms

2.1.7.2. Safety Docs

2.1.7.3. Status Rpts

2.1.7.3.1. SAE Rpts

2.1.8. Site Mgmt

2.1.8.1. Initiation

2.1.8.2. Mgmt

2.1.8.3. Notes-Mtgs-Comms

2.1.8.4. Selection

2.1.8.5. Setup Docs

2.1.8.6. Site Subj Materials

2.1.9. Statistics

2.1.9.1. Analysis

2.1.9.2. Misc

2.1.9.3. Notes-Mtgs-Comms

2.1.9.4. Reports

2.1.9.5. SAP

2.1.10. Trial Oversight

2.1.10.1. Committees

2.1.10.2. Notes-Mtgs-Comms

2.1.10.3. Status Reports

2.1.10.4. Study Plans SOPs

2.1.10.5. Team Structure

2.2. Clinical Assays

2.2.1. [Assay Name]-[Partner] - COPY ME

2.3. Non-Study Clinical Docs

2.4. Sub-Team Docs

3. Policy Access & Introduction (PAI)

3.1. Advocacy & Communications (A&C)

3.1.1. Conf & Events

3.1.2. Int Comms

3.1.3. Manuscripts

3.1.4. Media Materials

3.1.5. Online Comms

3.1.5.1. Social Media

3.1.5.2. Website & Blogs

3.1.6. Print & Electronic

3.1.6.1. Factsheets

3.1.6.2. Logos

3.1.6.3. Multimedia

3.1.6.4. Report

3.2. Ethics Review

3.3. Health Economics & Outcomes Research (HEOR)

3.4. Vaccine Introduction & Impact (VI&I)

3.5. Value Proposition (VP)

3.6. Sub-Team Docs

4. Non-Clinical Toxicology (NonClinTox)

4.1. Studies

4.1.1. [Partner]-[Protocol #] - COPY ME

4.2. Test Article Info

4.3. Sub-Teams Doc

5. Project Management (ProjMgmt)

5.1. Admin

5.2. Contact Lists

5.3. INT Mtgs

5.3.1. YYYYMMMDD - Meeting Title - COPY ME

5.4. EXT Mtgs

5.4.1. YYYYMMMDD - Meeting Title - COPY ME

5.5. Onboarding

5.6. Proj Artifacts

5.7. Risk Mgmt

5.8. Tactical Docs

5.8.1. [Project Name] Current Tactical Docs

6. Chemistry, Manufacturing & Controls (CMC)

6.1. [Partner Name] - COPY ME

6.1.1. [Phase] {Drug Substance or Drug Product] - COPY ME

6.1.1.1. Dev

6.1.1.2. GMP

6.1.2. Cell Bank

6.1.2.1. Dev

6.1.2.2. GMP

6.1.3. [Partner Name] Mtgs & Docs

6.2. Stability

6.3. Sub-Team Docs

7. Pre-Clinical Research (Preclin)

7.1. Discovery & Lead Candidate Selection

7.2. Pre-Clinical Assays

7.2.1. [Assay Name]-[Partner] - COPY ME

7.3. Proof of Concept Studies

7.3.1. [Study-ID] - COPY ME

8. Literature

9. Background

10. Regulatory (Reg)

10.1. [Master File Name & Number]

10.1.1. Drafts

10.1.1.1. [Module Number]

10.1.2. Final

10.1.2.1. [Module Number]

10.2. [NRA] - COPY ME

10.2.1. [Submission Type & Number]- (Product Name) - COPY ME

10.2.1.1. [Serial Number] - COPY ME

10.2.1.1.1. Drafts

10.2.1.1.2. Final

10.2.1.1.3. Timeline

10.2.1.1.4. Submission Inputs

10.2.1.2. Correspondence

10.2.2. [Meeting Name & Number] - COPY ME

10.2.2.1. Briefing Package

10.2.2.2. Correspondence

10.2.2.3. Request

10.3. WHO

10.3.1. [Submission Type & Date ] (Product Name)

10.3.1.1. Correspondence

10.3.1.2. [Submission Date] - COPY ME

10.3.1.2.1. Drafts

10.3.1.2.2. Final

10.3.1.2.3. Timeline

10.3.1.2.4. Submission Inputs

10.3.2. [Meeting Name & Date]

10.3.2.1. Briefing Package

10.3.2.2. Correspondence

10.3.2.3. Request

10.4. REG Sub-Team