Free Resources
& Downloads
Industry documents, white papers, articles, and presentations to support your clinical data management work.
Free Resources
At TriTiCon we strongly believe in open resource and knowledge sharing to improve the quality and efficiency of clinical development. You will find a repertoire of free resources below. Feel free to contact us if you want the original PowerPoint, Word file or manuscript.
Free Knowledgeworld Resources
Downloadable resources from TTC Knowledgeworld
Free Knowledgeworld Resources
Downloadable resources from TTC Knowledgeworld
B02. Outsourcing in Clinical Development
Qualification Visit - Agenda and Plan
Template for vendor qualification visits
Qualification Visit – Report
Report template for qualification visits
B03. Oversight in Clinical Development
Oversight in ICH GCP E6 R3Oversight in ICH GCP E6 R3 and Differences wrt R2
Differences with regards to R2
ICH E6 R3 Sponsor oversight definition v1.0
Focused extraction of sponsor oversight - ICH E6(R3).
Oversight - Focus per sourcing model matrix
A matrix outlining suggested oversight activities and controls.
Oversight - TriTiCon Methodology at a glance
A concise overview of the TriTiCon approach to sponsor oversight — covering the core definition, the critical distinction between being part of the process versus overseeing it, and the three-level framework for structuring oversight effectively.
Oversight - Trial-Level Oversight QCs and Spot Checks
A practical reference document providing ready-to-use QC-based oversight activities and spot checks for six clinical trial disciplines — Clinical Data Management, Statistical Programming, Safety/AE Reporting, Clinical Trial Management, Site Management, and Biostatistics — each with defined sampling guidance, oversight questions, and interpretation of findings.
Oversight - Trial level Oversight metrics and approvals
Trial-level oversight framework defining KPIs, quality indicators, and approval checklists across Clinical Data Management, Statistical Programming, Safety Reporting, Trial Management, Site Management, and Biostatistics to monitor vendor performance within an individual clinical trial.
C06. Introduction to (e)COAand (e)PRO
12 ePRO terms you need understand - a free TriTiCon Field Guide
This free field guide breaks down 12 essential ePRO terms that frequently create confusion across sponsors, CROs, and vendors. It provides practical, real-world definitions to help teams align on concepts, avoid miscommunication, and design more reliable patient-reported outcome data collection.
C06 Validated Instruments for patient-reported outcomes in clinical trials
This workbook lists commonly used validated instruments across therapeutic areas. It is intended as a starting point for instrument selection — not a regulatory or licensing reference. Always verify the latest licence terms, recall windows and translation availability with the steward (provider) before locking your protocol.
X01. The Practical Use of AI in Clinical Development
Video lesson - Chapter 1, part 1
First part of Chapter 1 from the course X01. The Practical Use of AI in Clinical Development.
Video lesson - Chapter 1, part 2
Final part of Chapter 1 from the course X01. The Practical Use of AI in Clinical Development.
TriTiCon Quality Documents
Our complete QMS: Policies, SOPs, and Templates
TriTiCon Quality Documents
Our complete QMS: Policies, SOPs, and Templates
Policies (POL)
POL-01 Company Core Policy
POL-02 Company Management
POL-03 Company Conduct
POL-04 Privacy Policy
POL-05 IT and Data Handling Policy
Standard Operating Prodecures (SOP)
SOP-01 Quality Management System
SOP-01 Index 01 – Document Index
Index of TTC policies, SOPs, Guidelines and Checklists
SOP-02 Client and Vendor Engagements
Templates (TMP)
TMP-01 GDPR Consent Form – Employee
TMP-02 GDPR Consent Form – Emergeny Contact
TMP-03 GDPR – Data Handling Officer
TMP-04 Employee Assurance of Training and Understanding of Compliance Documents
TMP-06 Client Engagement Checklist
TMP-07 Service Provider Qualification Checklist
TMP-08 Vendor Assessment Form
TMP-09 Client Engagement Close Out Checklist
Articles
eClinical articles and externally published content
Articles
eClinical articles and externally published content
eClinical Articles Series
Article 1: Breaking up with history
Challenging the illusion of the low-risk approach
Article 2: Getting Started
Strategy and Foundation
Article 3a: Selecting systems
If, how and what
Article 3b: Selecting EDC Systems and Services
From theory to practice
Externally Published
Ongoing training fills data management knowledge gaps
How continuous learning addresses skills gaps in clinical data management
Pharma Tech Outlook, 2019
Bringing Strategic Consultancy Expertise in Clinical Data Handling
White Papers and Guides
In-depth resources on eCOA, biometrics, and clinical standards
White Papers and Guides
In-depth resources on eCOA, biometrics, and clinical standards
eCOA White Paper
Data Handling and Change of eCOA Data
Comprehensive white paper on eCOA data management
eCOA White Paper – Addendum 1
Additional guidance and updates
Guides
Oversight of Biometrics Activities
Best practices for biometrics oversight
Data and Output Delivery Checklist
Comprehensive checklist for data deliveries
Clinical Standards Overview
Overview of key clinical data standards
ePRO: Cross-Trial Libraries, Standards and Best-Practice
Guide to ePRO implementation and best practices
Presentations
Conference presentations and industry talks
Presentations
Conference presentations and industry talks
Source Data Handling in Oncology
Clinical Operations in Oncology Trials Europe, Nov 2019
Risk Based Monitoring in eCOA
CRF Health Scientific Forum, May 2017
Risk Based Monitoring for Data Management
DADM General Assembly, January 2017
Patient Reporting Behavior in Event Driven Indications
CRF Health Scientific Forum, Oct 2015