Industries: Pharma / Biotech

Clinical Document Management – A Trial-by-Trial Approach to Compliance

Course Director: Kay Monroe

Course Description - Course runs 9:00 to 5:00 both days

This course explores the international challenges of trial records management: people, culture, and systems. With so many trials occurring in Brazil, Russia, India, China, South Korea and Turkey, as well as the US, Canada and Europe, the confluence of cultures presents unique challenges. This course offers suggestions for building a workable, sustainable system for clinical documents and data with practical templates, processes and solutions to common problems. This course also reviews the range of documentation that sponsors and sites need to control and generate for a successful outcome. It also addresses what to do with records once a trial is complete.

Who Should Attend

Conducting clinical trials and accruing accurate and viable data is the most expensive component of the drug development paradigm. Clinical teams are held accountable to ensure the most efficient and effective delivery of high quality data from each and every trial that they complete. Even in this day of electronic data transfer for many aspects of a trial, how those data are collected, reviewed, archived and retrieved has become a logistical nightmare for many clinical teams. This course aims to support all those team members who touch some aspect of clinical documentation in understanding the importance of the data/paper flow based on the specifics of their clinical protocol and existing systems. Typical attendees include:

  • Project Managers, Directors and Leaders
  • CRO Staff Members
  • Site and Sponsor Staff Members
  • Clinical Investigators and Study Coordinators
  • Clinical Operations Directors and Senior CRAs
  • Clinical Trial Managers, Monitors and Associates
  • Medical Affairs and Clinical Operations Professionals
  • Quality Assurance Personnel
  • Central Records Staff
  • Document Management Staff
  • Regulatory Managers

First Day


  • The Regulatory environment as it relates to trial documentation
  • Requirements for the protocol and the geographical area of testing
  • Roles and Responsibilities of the Sponsor, the Investigator, the CRO
  • Documentation Systems: Paper, Electronic and Hybrid
  • Leadership Skills

Case Study Exercise

  • Using study basics (protocol and transfer of obligations document), create your clinical team and the roles/responsibilities for each
  • Create a RACI document and Communication matrix for the team


  • What SOPs are needed?
  • Who is responsible for the SOPs?
  • Training on SOPs, other study procedures and the process/system for managing trial documentation

Essential Documents & Trial Master File

  • What are Essential Documents and what drives the list for your trial?
  • Creating and Customizing your Essential Document List
  • Differences between the Essential Document List and the TMF
  • Strategies for managing documents at multiple sites

Second Day

Trial Conduct – Managing the Day-to-Day Documents

  • Establishing a reliable baseline
  • How to manage data generated during the trial
  • The case report form book
  • Data collection, records of verification (QA/QC)
  • Lab information
  • What to do with data/observations not on protocol
  • Handling amendments to the protocol and adjustments to data collection activities
  • Monitoring reports – who generates, reviews, sees? Where do they go?
  • Deviations – who conducts, reviews, archives?
  • Correspondence during the trial
  • Agendas and minutes generated during the trial

Continuing Case Study Exercise

  • Resolve documentation questions and issues from sites, PI's and monitors
  • Utilize the system built thus far to ensure consistent document management

Trial Closeout

  • What data/documents need to come together?
  • Retiring SOPs when the trial is over
  • Who keeps what records after the trial?
  • Transmitting data for analysis and the regulatory submission process
  • What to do with trial data after closeout. Who owns it? How is it accessible?

GCP Audits – Before, during and after the Trial

  • Preparing for them and conduct during an audit
  • What an auditor looks for
  • Auditing reports – who generates, reviews, sees? Where do they go?

Learning Objectives

Companies in the business of conducting clinical trials must understand that each trial is different and requires trial-specific processes for gathering data, managing it, transporting it to the right place and archiving it. Trials require a complete web-work of documents and records, from contracts, protocols, investigator brochures, and standard operating procedures, to data collected during the conduct of the trial and transmitted to the Sponsor for analysis and regulatory use. Even if a Sponsor has a robust document management system, to be successful, a clinical trial must address records management unique to the study itself and incorporate the various resources allocated to the conduct of the trial. By the end of the course, participants should be able to do the following:

  • Understand the documentation requirements for a trial based on the protocol and the geographical location
  • Review and assess documentation needs in the context of paper, electronic and hybrid document management systems
  • Understand the roles and responsibilities of the team members with regards to the trial documentation; understand those roles from the Sponsor, site and CRO perspective
  • Determine what SOPs are required to run the trial and who has responsibility for them
  • Know what the Essential Document list should be for the protocol you are testing
  • Understand what the Trial Master File is made of and how this is different from the Essential Document list
  • Be prepared for audits; site, CRO and in-process trial audits


"The course delivered on-site was top notch. It exceeded my expectations, especially in the personalized exercises using our documentation examples. The Course Director was an amazing facilitator who balanced slide content, exercises and anecdotal experiences to present the course content." Tracy U., Chief, Regulatory Operations, USAMMDA
"This course was really helpful for me. The additional material and examples shared with the class will be really helpful to implement a better control of the TMF. The Course Director welcomed our opinions and questions, she was always willing to give us her valuable point of view." Alicia Huidobro, Head of Documentation, Probiomed S.A. de C.V
"Excellent course! With the material provided, I can implement in practice what has been learned." Aaron M., Clinical Research Department, Probiomed
"I have enjoyed all of my courses with CfPIE. The knowledge I have received in all my courses has helped me tremendously." Barbara K., MCA Compliance & Tracking Coordinator, Smith and Nephew
"I thoroughly enjoyed this training. It satisfied all my needs and answered previously un-answered questions. The Course Director has a natural talent to present this class and masterfully guided it along. The group members were fantastic! The location was great as well." Tanya B., Records Analyst, Cephalon
"I felt that the course director was very knowledgeable, professional, and friendly. Kay's extensive knowledge and willingness to share was not only refreshing and unexpected, but inspiring." Fatima S., Document Manager, Novartis Pharmaceuticals
"I loved the course and the instructor. Class interaction was great and I learned a lot from fellow class members, as well as from the course director. I would highly recommend this course." Carol S., Sr. TMF Manager, UCB
"Very informative, I learned so much to take back to the workplace!" Brenda H., Manager, QA Operation, Pfizer