Protocol & Study Design
Foundational templates for protocol authoring, statistical analysis, and clinical study reporting — including the ICH M11 standard and TransCelerate's Common Protocol Template.
Common Protocol Template (CPT) v11
Industry-standard protocol template aligned to ICH M11. Includes endpoint libraries from CDISC. The most widely-adopted protocol template globally.
Statistical Analysis Plan (SAP) Template
SAP template aligned with ICH E9, integrates with the Common Protocol Template and CSR. Includes proposed model content and harmonized structure.
Clinical Study Report (CSR) Template
CSR template aligned with ICH E3. Designed to integrate with CPT and SAP for end-to-end content reuse across the protocol-to-report lifecycle.
ICH M11 Protocol Template & Tech Spec
The international harmonized standard for clinical study protocols. Required reference for global trials. Now adopted by FDA, EMA, PMDA, NMPA.
Master Protocol Template (Platform Trials)
Five templates for platform trials including Master Protocol, ISA, and SAP — designed for adaptive and multi-arm trial designs.
FDA-NIH Common Protocol Template
Joint FDA-NIH protocol template for IND-required Phase 2/3 trials of drugs and biological products. Specifically structured for U.S. submissions.
Nonclinical Study Templates
Common templates for preclinical/nonclinical studies — addresses CRO pain point of varying sponsor formats. Includes protocol and report templates.
Monitoring & Risk-Based Quality Management
Risk-based monitoring frameworks, quality risk management plans, and central monitoring tools — the gold standard from TransCelerate's RBM initiative.
Risk Assessment & Categorization Tool (RACT)
The industry-standard risk assessment tool for clinical trials. Includes template plus worked example covering risk identification, categorization, and mitigation.
Integrated Quality Risk Management Plan (IQRMP)
Framework for integrated quality risk management aligned with ICH E6(R3). Combines quality, risk, and monitoring planning in one document.
Risk Indicator Library
Pre-built library of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) for clinical trials. Maps risks to monitoring activities.
ICH E6(R3) Good Clinical Practice
The updated GCP guideline — the regulatory bible for clinical trials. Adopted by FDA, EMA, PMDA. Mandatory reference for all sponsor and CRO operations.
FDA Risk-Based Monitoring Guidance
FDA's official guidance on a risk-based approach to monitoring clinical trials. Required reading for U.S. trial monitoring strategies.
Central Monitoring Implementation Guide
Practical guide and sample workflows for implementing central monitoring at sponsor or CRO level. Includes case studies from member companies.
Site Qualification & Training
Investigator site forms, GCP training mutual recognition, EDC training framework — TransCelerate's SQT initiative is the most cited resource in this category.
Facility Profile Form
Standardized site capability database form. Used by sponsors and CROs to assess potential investigator sites. Reduces duplication across studies.
Financial Disclosure Form
21 CFR Part 54-aligned financial disclosure form for clinical investigators. Required for FDA submissions involving covered clinical studies.
Standardized Investigator CV Template
Harmonized CV format accepted across TransCelerate member companies. Reduces redundancy of investigator submitting different CV formats per sponsor.
FDA Form 1572 — Investigator Statement
Mandatory FDA form for clinical investigators in IND-conducted studies. Investigator commitment to comply with regulations.
FDA Form 1571 — IND Application
Investigational New Drug application form. Submitted by sponsors to begin clinical trials with new drugs in the U.S.
GCP Training Mutual Recognition Criteria
Minimum criteria framework allowing GCP training completed for one TransCelerate member to be recognized by others — eliminates redundant training.
Site Investigator Training Modules
Video-based training modules on Principal Investigator oversight and foundational clinical research concepts. Maintained by Society for Clinical Research Sites.
EDC Mutual Recognition Process
Framework for mutual recognition of EDC system training across companies — investigators don't need to retrain on the same EDC for each new sponsor.
Safety & Pharmacovigilance
Adverse event reporting, ICSR processes, signal detection — covering FDA, EMA, and ICH safety standards.
ICH E2A — Clinical Safety Data Management
Definitions and standards for expedited reporting of adverse drug reactions in clinical trials. Foundational pharmacovigilance reference.
ICSR & Automation Technologies Tool (IATT)
Interactive tool mapping pharmacovigilance technologies to ICSR process steps. Helps companies identify automation opportunities in safety reporting.
FDA Combination Products Safety Implementation Guide
Practical guide for pharmaceutical manufacturers on FDA Post Marketing Safety Reporting for Drug-Device Combinations. Includes webinar.
FDA Safety Reporting Portal
FDA's official portal for safety reports including FAERS, MAUDE, and IND safety reports. Required submission system for U.S. trials.
EudraVigilance Reporting Guidance
European Medicines Agency's pharmacovigilance database submission requirements. Required for trials conducted in EU member states.
Data Management & eClinical
CDISC standards, FHIR mapping, eTemplate digitization — the data interoperability layer of clinical research.
CDASH / SDTM / ADaM Standards
FDA-required data standards for clinical trial data collection (CDASH), tabulation (SDTM), and analysis (ADaM). Mandatory for NDA/BLA submissions.
FHIR-to-CDISC SDTM Mapping
Mapping of HL7 FHIR data elements to CDISC SDTM standards for labs, AEs, and Schedule of Activities. Enables EHR-to-trial-data interoperability.
eTemplate Suite (eCPT, eSAP, eCSR)
Technology-enabled MS Word templates with add-ins enabling content reuse across protocol-to-CSR lifecycle. Source code now publicly available.
Unified Study Definitions Model (USDM)
Digital data flow standard developed by CDISC and the DDF Initiative. Key part of the future protocol digitization landscape, aligned with ICH M11.
Regulatory Submissions & Compliance
FDA, EMA, MHRA submission workflows, eCTD structure, and 21 CFR Part 11 electronic records compliance.
FDA Guidance Document Database
Searchable database of all FDA guidance documents — clinical trials, GCP, electronic records, manufacturing, and more. The single most important regulatory reference.
EMA Scientific Guidelines
European Medicines Agency's scientific and regulatory guidelines for clinical trials, including CTIS submission requirements under EU CTR.
21 CFR Part 11 Compliance Guidance
FDA's regulation on electronic records and electronic signatures. Required for any clinical trial system handling regulated data.
ICH eCTD Specifications
Electronic Common Technical Document specifications — the global standard structure for regulatory submissions to FDA, EMA, PMDA, NMPA, and Health Canada.
EU Clinical Trials Information System (CTIS)
Mandatory submission system for clinical trials in the EU under EU CTR Regulation 536/2014. Single submission for all EU member states.
MHRA Clinical Trials Guidance
UK Medicines and Healthcare products Regulatory Agency clinical trial guidance — particularly relevant post-Brexit for UK trial submissions.
Patient Engagement & Consent
Patient-centric trial design, eConsent frameworks, decentralized trial methodologies, and data return considerations.
Personalized Clinical Trials Framework
Practical considerations to support sponsors, sites, and third parties in delivering patient-centric trial experiences with options like telehealth and home visits.
eConsent Implementation Assets
Case studies and survey data on member company eConsent usage. Provides empirical evidence of value and impact for adoption decisions.
Data Return to Participants
General considerations for returning study data to clinical trial participants. Includes Socialization Presentation, Considerations Guide, and Template.
Modern Methodologies in Clinical Research
Workshop output exploring decentralized trial topics — telemedicine, direct-to-patient shipping, home health visits, local lab usage.
AVD Clinical Original Content
Documents authored by AVD Clinical — original SOPs, AI-customized templates, and intelligence reports. Available exclusively here.
AI-Customized SOP Generator
Enter your protocol details — receive a fully-customized Standard Operating Procedure with your study specifics filled in. The AI does the work.
2026 Phase 2 Site Cost Benchmark Report
Aggregated per-patient cost data across therapeutic areas, geographies, and site types. Benchmark your trial costs against the industry.
AVD Budget & Feasibility Calculator
Working clinical trial budget calculator with per-patient cost, monitoring cost, regulatory cost, and contingency formulas built in.
Industry AI Intelligence Tracker
Live map of what pharma, biotech, EMR vendors and clinical AI startups are building. Continuously updated. The Bloomberg of clinical AI.
Update Tracking Service
The first service of its kind — login once, pick the templates you care about, get email alerts when TransCelerate, ICH, FDA or NIH update them.