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
$7912 documentsBest 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
Monitoring Bundle
$4914 documentsBest 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
Budget Bundle
$4911 documentsSites & 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
Site Closeout Bundle
$499 documentsSites / 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
QA / Compliance Bundle
$9913 documentsQA 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
PHI / HIPAA Privacy Bundle
$9910 documentsPrivacy & 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
Inspection Readiness Kit
$1498 documentsRegulatory Inspection 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
Validation / Electronic Records Bundle
$14913 documentsSystem Validation
User Requirements Specification (URS)
Functional Requirements Specification (FRS)
Design Specification
System Risk Assessment
Validation Plan
IQ / OQ / PQ Protocols & Reports
Traceability Matrix
Electronic Records Assessment
Validation Summary Report
Change Control Form
Release Notes Template
Backup & Recovery Test Report
System Decommissioning Plan
Sponsor Bundle
$9911 documentsSponsors
RFP Template
Feasibility Questionnaire
Sponsor Feasibility Questionnaire
Sponsor Oversight Plan
CRO Oversight Tracker
Vendor Oversight Plan
Study Startup Tracker
Site Performance Report
Risk-Based Monitoring Plan
Study Closeout Tracker
Document Exchange Checklist
CRO Bundle
$999 documentsCROs
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
Document Exchange Checklist
Patient / Subject Bundle
$4914 documentsSites & 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
Individual Templates — $9 each (or free with signup)