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Compliance In Focus
Posted by Deborah Rovniak on Tue, Mar 2, 2021

Clinical Data Management: 4 Steps To Ensure Success

Good clinical data management is essential to every successful trial.


We all know this, but sometimes our teams forget the fundamentals.

Like Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP) are based on regulations and guidance. Specifically, clinical research sponsors, principal investigators, and others can refer to the guidelines outlined by the Society for Clinical Data Management and 21CFR Part 11 regarding data management of electronic records.

Since the GCDMP guidelines are over 500 pages long, here’s a short overview.

A Guide To Good Clinical Data Management Practices

1. Create A Data Management Plan

Prior to beginning enrollment, all clinical studies should have a documented plan detailing how they will securely collect and store data. The goal is to outline for all stakeholders how you will collaborate during the trial.

At a minimum, your data management plan should include:

  • Who will maintain your database or electronic data capture system (EDC) and how you’ll share and analyze information
  • A definition of personnel and roles — for example, who will review and sign off on data
  • A short summary of your study protocol and on-site or remote activities
  • Which medical coding dictionaries you will use for the study and any specific naming conventions or acronyms
  • Who will be responsible for protocol and study activities from study start-up until database closeout

Your plan should also include timelines for all deliverables related to clinical data management, including:

  • Protocol finalization
  • Case report form (CRF) development
  • Database design
  • Data validation
  • Dates for first and last patient visits
  • Date when the last CRF is entered
  • Date to complete the last query or discrepancy
  • Database audit
  • Database lock
  • When the study data will be archived

2. Develop Case Report Forms And Electronic Data Capture Systems

All key stakeholders should be involved in setting up case report forms and electronic data capture systems. That includes the sponsor, internal study team, data entry personnel, biostatisticians, and clinical operations personnel.

Case Report Forms

As you develop case report forms, you’ll need to review them against the protocol and the safety/efficacy endpoints to assure all endpoint data is being collected.

All CRF questions, prompts, and instructions or guidelines should be clear and concise. Avoid redundancy or asking questions that may introduce bias.

You also need to consider how you will manage updates to these forms and ensure you are always using the correct version.

Selecting and Configuring Electronic Data Capture Systems

As you set up your electronic data capture system, you’ll want to consider similar criteria. Be sure you’re following accepted standards outlined by the Clinical Data Interchange Standards Consortium (CDISC) and Clinical Data Acquisition Standards Harmonization (CDASH) whenever possible. These standards ensure you are collecting data consistently across studies and entering it correctly into the Study Data Tabulation Model (SDTM).

Your data collection methods should be clearly traceable and transparent to regulators who review it later.

Consider how your EDC system will allow appropriate personnel to make edits and retain a revision history.

The FDA states that EDC systems should use “secure, computer-generated, time-stamped audit trails” to record entries and any changes made to electronic data.

Those changes should not obscure any previously recorded data.

You will also need to consider data privacy protections, such as passwords and safeguards against external threats, including hackers.

Finally, make sure your EDC system is set up in a way that will be easy for everyone on your team to use. Conducting user testing to identify challenges beforehand can help you avoid frustrations later.

3. Establish Study Roles

Each person involved with the study has different roles and responsibilities when it comes to using your EDC system. Some roles are responsible for performing certain tasks and/or accountable for ensuring those tasks are completed within established standards, while others need to be consulted or informed.

A RACI chart outlining each of these roles (responsible, accountable, consulted, and informed) can help you document these responsibilities.

Once you have done this, assign privileges to roles within your EDC system based upon the duties they will perform in the study.

For instance, principal investigators are the only role authorized to sign forms.

At a minimum, the roles should be listed or a reference should be made to a document where the roles are described. A detailed description of each role and the associated privileges is optimal.

Describe your procedure(s) or refer to your organization’s SOPs for defining, creating and maintaining system user roles and access. This description should include the process for revoking access.

Because the EDC system is used by different site staff and sponsor team members, access needs to be considered for all. Where input or review of data is required within the system, user roles and responsibilities should be defined and documented to identify specific access privileges or rights.

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4. Conduct Training

Each user should be able to access data according to their role. 

Users can reference data management standards, including those set forth by ISO, the International Conference on Harmonisation (ICH), Health Level 7 (HL7), CDISC, and CDASH.

Your team should review 21CFR Part 11 to ensure everyone follows the proper protocol for electronic records and electronic signatures.  

Take the time to train all users on how to use your EDC system as well. Your system may be configured differently than the one they’ve used in the past.

Once you have completed training for everyone, be sure to document it.

How IMARC Research Can Help

These best practices can go a long way to improve data quality, whether you are conducting research on-site, remotely, or using a hybrid model.

However, it can be difficult to find the time to do all this before your trial begins, especially if your team does not have a designated data manager.

Enlisting a third party for clinical data management support can help you follow an established process to ensure compliance throughout the trial.

IMARC’s experienced data managers can help you select the right electronic data capture system, build it according to your specifications and assist research coordinators and monitors with data entry and review. If you have decided to use electronic patient-reported outcomes, such as questionnaires, we can help you manage that process and ensure compliance.

We can also sort, clean, and analyze your clinical trial data and assist with database locking as your trial comes to a close.

Contact us today to discuss how we can help.

Topics: Clinical Data Management


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