SOPs & Templates Marketplace

Clinical research tools,
built for the people who do the work.

GCP-aware SOPs, checklists, and templates for sites, CROs, sponsors, QA teams, and patients. Free with signup, or unlock bundles and unlimited access.

🎁 Free account includes one SOP, checklist, or template of your choice. Sign up free →  ·  View all plans
Important: All templates are operational tools that require customization for your specific study, protocol, sponsor requirements, IRB/EC expectations, local law, and internal QA review. AVD Clinical does not certify regulatory compliance. Always consult qualified QA and legal professionals before operational use.
Best Value — Bundle Deals
Site Startup Bundle
$79 12 documents Best for Sites
  • Site Feasibility Questionnaire
  • Site Qualification Visit (SQV) Checklist
  • SQV Report Template
  • Site Initiation Visit (SIV) Checklist
  • SIV Report Template
  • Delegation of Authority (DOA) Log
  • Staff Training Log
  • CV and License Tracker
  • Protocol Training Log
  • Regulatory Binder Checklist
  • Site Activation Checklist
  • Essential Documents Checklist
Buy Bundle — $79 Save vs. individual
Monitoring Bundle
$49 14 documents Best for CRAs
  • Monitoring Visit Report (IMV)
  • Pre-Study Visit Report
  • Site Qualification Visit Report
  • Site Initiation Visit Report
  • Interim Monitoring Visit Report
  • Remote Monitoring Report
  • Closeout Visit Report
  • Source Data Verification (SDV) Checklist
  • Source Data Review (SDR) Checklist
  • Query Follow-Up Tracker
  • Monitoring Follow-Up Letter
  • Monitoring Action Item Tracker
  • Risk-Based Monitoring Plan
  • Central Monitoring Checklist
Buy Bundle — $49
Budget Bundle
$49 11 documents Sites & CROs
  • Site Budget Template
  • Sponsor Budget Template
  • CRO Budget Template
  • Per-Visit Budget Template
  • Startup Fee Template
  • Screen Failure Fee Template
  • Patient Reimbursement Template
  • Invoice Tracker
  • Payment Milestone Tracker
  • Pass-Through Cost Tracker
  • Amendment Budget Impact Template
Buy Bundle — $49
Site Closeout Bundle
$49 9 documents Sites / Sponsors
  • Site Closeout Checklist
  • Site Closeout Report
  • IP Reconciliation Checklist
  • Final Monitoring Report
  • eISF Reconciliation Checklist
  • TMF Reconciliation Checklist
  • Archive Transfer Form
  • Closeout Follow-Up Letter
  • Final Document Request Letter
Buy Bundle — $49
QA / Compliance Bundle
$99 13 documents QA Teams
  • CAPA Form
  • CAPA Tracker
  • Protocol Deviation Form
  • Deviation Tracker
  • Root Cause Analysis Template
  • Risk Assessment Template
  • Internal Audit Checklist
  • Vendor Qualification Checklist
  • Inspection Readiness Checklist
  • Evidence Request Tracker
  • SOP Review Log
  • Training Compliance Tracker
  • Change Control Form
Buy Bundle — $99
PHI / HIPAA Privacy Bundle
$99 10 documents Privacy & Compliance
  • PHI Access Request Form
  • PHI Disclosure Log
  • Minimum Necessary Access Checklist
  • Consent Withdrawal Form
  • Family Access Consent
  • Emergency Access Review Log
  • Breach Assessment Template
  • Incident Response Form
  • Data Retention Checklist
  • Privacy Training Attestation
Buy Bundle — $99
Inspection Readiness Kit
$149 8 documents FDA / EMA Readiness
  • Inspection Readiness Checklist
  • Mock Inspection Agenda
  • Staff Interview Preparation Guide
  • Evidence Request Tracker
  • TMF / eISF Review Checklist
  • CAPA Response Template
  • Inspection Response Tracker
  • Regulatory Binder Review
Buy Kit — $149
Validation / 21 CFR Part 11 Bundle
$149 15 documents System Validation
  • User Requirements Specification (URS)
  • Functional Requirements Specification (FRS)
  • Design Specification
  • System Risk Assessment
  • Validation Plan
  • IQ Protocol & Report
  • OQ Protocol & Report
  • PQ Protocol & Report
  • Traceability Matrix
  • Part 11 Assessment
  • Validation Summary Report
  • Change Control Form
  • Release Notes Template
  • Backup & Recovery Test Report
  • System Decommissioning Plan
Buy Bundle — $149
Sponsor Bundle
$99 12 documents Sponsors
  • RFP Template
  • Feasibility Questionnaire
  • Site Selection Checklist
  • Sponsor Oversight Plan
  • CRO Oversight Tracker
  • Vendor Oversight Plan
  • Study Startup Tracker
  • Enrollment Dashboard Template
  • Site Performance Report
  • Risk-Based Monitoring Plan
  • Study Closeout Tracker
  • Document Exchange Checklist
Buy Bundle — $99
CRO Bundle
$99 10 documents CROs
  • CRO Oversight Tracker
  • Vendor Oversight Plan
  • Risk-Based Monitoring Plan
  • Central Monitoring Checklist
  • Query Follow-Up Tracker
  • Monitoring Action Item Tracker
  • Site Performance Report
  • Study Startup Tracker
  • IQRMP Framework
  • Document Exchange Checklist
Buy Bundle — $99
Patient / Subject Bundle
$49 14 documents Sites & Patients
  • Subject Intake Form
  • Medical History Form
  • Medicine Reminder Template
  • Family Sharing Consent
  • Emergency Profile Form
  • Lab Upload Checklist
  • Imaging Upload Checklist
  • Document Sharing Consent
  • Appointment Reminder Template
  • Reimbursement Request Form
  • Travel Support Form
  • Patient Study Visit Checklist
  • Teleconference Consent Template
  • Insurance Upload Checklist
Buy Bundle — $49
IRB / Consent & ICF Bundle
$49 12 documents Sites · Sponsors · IRBs
  • Informed Consent Form (ICF) Template — Adult
  • Informed Consent Form — Short Form (non-English)
  • Assent Form — Pediatric (7–12 years)
  • Assent Form — Adolescent (13–17 years)
  • LAR (Legally Authorized Representative) Consent
  • Re-Consent / Protocol Amendment Consent Form
  • HIPAA Research Authorization (combined ICF)
  • Waiver of Consent Request Form
  • IRB Initial Submission Cover Letter
  • IRB Continuing Review Request
  • IRB Protocol Deviation / Amendment Notification
  • Consent Process Checklist
Buy Bundle — $49 Most requested category
Safety & Pharmacovigilance Bundle
$49 11 documents Sites · CROs · Sponsors
  • SAE (Serious Adverse Event) Report Form
  • SAE Tracker / Narrative Summary
  • Expedited Reporting Checklist (7-day / 15-day)
  • SUSAR Notification Template
  • AE / SAE Log
  • Adverse Event Grading Reference (CTCAE)
  • Safety Signal Assessment Form
  • Pharmacovigilance SOP Reference Card
  • Safety Review Meeting Agenda / Minutes
  • DSMB / DSMC Report Template
  • End-of-Study Safety Summary
Buy Bundle — $49
Medical Writing Bundle
$99 10 documents Medical Writers · CROs · Sponsors
  • Clinical Study Report (CSR) Skeleton — ICH E3
  • Protocol Synopsis Template
  • Investigator's Brochure (IB) Outline
  • Study Report Narrative Template
  • Patient Narrative Template
  • Integrated Summary of Efficacy (ISE) Outline
  • Integrated Summary of Safety (ISS) Outline
  • Medical Writing Style Guide (reference)
  • Table of Contents Template — CTD Module 5
  • Regulatory Submission Cover Letter Template
Buy Bundle — $99
Data Management Bundle
$49 9 documents Data Managers · CROs
  • Data Management Plan (DMP) Template
  • EDC User Acceptance Testing (UAT) Script
  • Data Validation / Cleaning Checklist
  • Query Management SOP Reference
  • Database Lock Checklist
  • Medical Coding SOP (MedDRA / WHO Drug)
  • CRF Completion Guidelines
  • Data Transfer Agreement Checklist
  • CDISC / SDTM Submission Readiness Checklist
Buy Bundle — $49
Regulatory Submissions Bundle
$99 11 documents Regulatory Affairs · Sponsors
  • FDA Form 1572 — Guidance & Checklist
  • IND Application Cover Letter
  • IND Annual Report Outline
  • NDA / BLA Submission Checklist
  • eCTD Module 5 Document Checklist
  • FDA Meeting Request Template
  • Pre-IND Meeting Briefing Document Outline
  • EMA Scientific Advice Request Outline
  • Clinical Trial Registration Checklist (ClinicalTrials.gov)
  • Regulatory Submission Tracker
  • Response to Agency Questions Template
Buy Bundle — $99
TMF / eTMF Bundle
$49 8 documents Sites · CROs · Sponsors
  • TMF Index Template (DIA Reference Model aligned)
  • TMF Reconciliation Checklist
  • eTMF SOP Reference Guide
  • Essential Documents Tracker
  • TMF Completeness Review Checklist
  • Document Filing / Naming Convention Guide
  • TMF Review Report Template
  • TMF Archive Transfer Form
Buy Bundle — $49
IP / Investigational Drug Bundle
$49 10 documents Pharmacists · Sites · Sponsors
  • IP Accountability Log
  • IP Receipt & Return Form
  • IP Dispensing Log
  • IP Temperature / Storage Monitoring Log
  • IP Reconciliation Checklist
  • IP Destruction Form
  • Randomization / Unblinding Log
  • Dose Preparation Record
  • IP Complaint / Deviation Form
  • Cold Chain Management Checklist
Buy Bundle — $49
Lab & Specimen Bundle
$49 9 documents Sites · CROs · Labs
  • Lab Manual Template
  • Specimen Collection & Handling SOP
  • Sample Tracking Log
  • Lab Reference Range Alert Form
  • Critical / Panic Value Notification Log
  • Biomarker / PK Sample Log
  • Central Lab vs. Local Lab Reconciliation
  • Lab Certification / Accreditation Tracker
  • Specimen Destruction Record
Buy Bundle — $49
Training & GCP Bundle
$49 8 documents Sites · CROs · Students
  • GCP Training Log
  • Protocol Training Acknowledgment Form
  • Staff Competency Assessment Form
  • Training Matrix Template
  • New Staff Onboarding Checklist
  • Sponsor / CRO Training Attestation
  • SOP Read & Understood Log
  • Training Plan Template
Buy Bundle — $49
Individual Templates — $9 each (or free with signup)
QA Reviewed
Delegation of Authority Log
Site Startup · Essential Doc
Free (1 pick)
QA Reviewed
Monitoring Visit Report
Monitoring · CRA Tool
Free (1 pick)
QA Reviewed
Site Qualification Visit Checklist
Site Startup · SQV
$9
Buy — $9
QA Reviewed
Site Initiation Visit Checklist
Site Startup · SIV
$9
Buy — $9
QA Reviewed
Staff Training Log
Site Startup · Training
$9
Buy — $9
QA Reviewed
SDV Checklist
Monitoring · Source Data
$9
Buy — $9
QA Reviewed
Remote Monitoring Report
Monitoring · Remote
$9
Buy — $9
QA Reviewed
Site Budget Template
Budget · Site Finance
$9
Buy — $9
QA Reviewed
Patient Reimbursement Template
Budget · Patient Support
$9
Buy — $9
QA Reviewed
CAPA Form
QA / Compliance
$9
Buy — $9
QA Reviewed
Protocol Deviation Form
QA / Compliance
$9
Buy — $9
QA Reviewed
PHI Disclosure Log
PHI / HIPAA · Privacy
$9
Buy — $9
QA Reviewed
Site Closeout Checklist
Closeout · Wrap-Up
$9
Buy — $9
QA Reviewed
Feasibility Questionnaire
Sponsor / CRO · Startup
$9
Buy — $9
QA Reviewed
Subject Intake Form
Patient / Subject
$9
Buy — $9
QA Reviewed
Part 11 Assessment Template
Validation · Part 11
$9
Buy — $9
QA Reviewed
Pharmacy Dispensing Log
Doctor / Pharmacy · IP Tracking
$9
Buy — $9
QA Reviewed
Drug Accountability Log
Doctor / Pharmacy · IP Accountability
$9
Buy — $9
QA Reviewed
Investigational Product Receipt Form
Doctor / Pharmacy · IP Receipt
$9
Buy — $9
QA Reviewed
Inspection Readiness Checklist
Inspection Readiness · FDA / EMA
$9
Buy — $9
QA Reviewed
Mock Inspection Agenda
Inspection Readiness · Preparation
$9
Buy — $9
QA Reviewed
Evidence Request Tracker
Inspection Readiness · Documentation
$9
Buy — $9
QA Reviewed
Informed Consent Form (ICF) Template
IRB / Consent · Adult ICF
Free (1 pick)
QA Reviewed
Assent Form — Pediatric
IRB / Consent · Pediatric
$9
Buy — $9
QA Reviewed
Re-Consent Form (Protocol Amendment)
IRB / Consent · Amendment
$9
Buy — $9
QA Reviewed
LAR Consent Form
IRB / Consent · Legally Authorized Rep
$9
Buy — $9
QA Reviewed
IRB Submission Cover Letter
IRB / Consent · Submission
$9
Buy — $9
QA Reviewed
Consent Process Checklist
IRB / Consent · Process QA
$9
Buy — $9
QA Reviewed
SAE Report Form
Safety / PV · Adverse Events
Free (1 pick)
QA Reviewed
AE / SAE Log
Safety / PV · Tracking
$9
Buy — $9
QA Reviewed
Expedited Reporting Checklist
Safety / PV · 7-day / 15-day
$9
Buy — $9
QA Reviewed
SUSAR Notification Template
Safety / PV · SUSAR
$9
Buy — $9
QA Reviewed
CSR Skeleton — ICH E3
Medical Writing · Clinical Study Report
$9
Buy — $9
QA Reviewed
Protocol Synopsis Template
Medical Writing · Protocol
$9
Buy — $9
QA Reviewed
Patient Narrative Template
Medical Writing · Narrative
$9
Buy — $9
QA Reviewed
Data Management Plan (DMP)
Data Management · DMP
$9
Buy — $9
QA Reviewed
Database Lock Checklist
Data Management · Lock
$9
Buy — $9
QA Reviewed
CRF Completion Guidelines
Data Management · CRF / EDC
$9
Buy — $9
QA Reviewed
FDA Form 1572 Guidance & Checklist
Regulatory · FDA
$9
Buy — $9
QA Reviewed
IND Application Cover Letter
Regulatory · IND
$9
Buy — $9
QA Reviewed
ClinicalTrials.gov Registration Checklist
Regulatory · Trial Registration
$9
Buy — $9
QA Reviewed
Response to Agency Questions
Regulatory · FDA / EMA Response
$9
Buy — $9
QA Reviewed
TMF Index Template (DIA Model)
TMF / eTMF · Index
$9
Buy — $9
QA Reviewed
TMF Completeness Review Checklist
TMF / eTMF · Review
$9
Buy — $9
QA Reviewed
Document Naming Convention Guide
TMF / eTMF · Filing
$9
Buy — $9
QA Reviewed
IP Temperature Monitoring Log
IP / Drug Mgmt · Cold Chain
$9
Buy — $9
QA Reviewed
IP Reconciliation Checklist
IP / Drug Mgmt · Reconciliation
$9
Buy — $9
QA Reviewed
Randomisation / Unblinding Log
IP / Drug Mgmt · Randomisation
$9
Buy — $9
QA Reviewed
Lab Manual Template
Lab / Specimens · Lab Manual
$9
Buy — $9
QA Reviewed
Sample Tracking Log
Lab / Specimens · Tracking
$9
Buy — $9
QA Reviewed
Critical Value Notification Log
Lab / Specimens · Safety Alerts
$9
Buy — $9
QA Reviewed
GCP Training Log
Training / GCP · Staff Training
Free (1 pick)
QA Reviewed
Protocol Training Acknowledgment
Training / GCP · Protocol
$9
Buy — $9
QA Reviewed
Staff Competency Assessment Form
Training / GCP · Competency
$9
Buy — $9
QA Reviewed
Training Matrix Template
Training / GCP · Planning
$9
Buy — $9

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