A Guide to Creating and Developing a Clinical Data Management Plan

Crafting an effective Data Management Plan (DMP) is crucial for outlining the essential elements of study execution. Created at the outset, the DMP mandates thorough planning, significantly contributing to the study's efficiency and data integrity. Most organisations utilise a DMP template attached to a SOP, which includes generic content.

How to create and finalise a Clinical Data Management Plan

Given the tight timelines during study setup, it can be tempting to only minimally update the DMP template. However, this approach often leads to inefficiencies later as Data Managers search through supporting documents for needed information.

The amount of detail in a DMP varies by Data Manager, and finding the right balance typically comes with experience. Developed using the study protocol, CRF/data collection forms, and SOPs/working instructions, the DMP should consider key factors for both the author and reviewer:

• Protocol Version: The protocol should be finalised or near final prior to the start of the DMP. Drafting the DMP too early poses the risk of irrelevant/redundant strategies being put in place, inaccurate information being reported, resulting in hours of re-work.
• SOPs/Standards: The applicable SOPS and versions, as well as standard to be followed, should be listed, i.e., CRO’s, Sponsor’s, or a mix of both SOPs to be followed, omitting these details could result in an incorrect process being followed.
• Study Timelines: More often than not a delay in the initial study set-up phases can threaten overall study timelines. The DM needs to have strategies in place to mitigate delays that could jeopardise the important first patient first visit date. If a staggered EDC deployment approach is needed, the DMP should include the strategy, i.e., the number of deployments planned, visits/forms/ automatic edit checks to be included in each deployment.
• Type and Phase of Study: Ensuring the data cleaning strategy for the study is documented. Considering that a phase III study would be different from that of a retrospective observational study, the strategy should be phase specific. This will avoid unrealistic/unnecessary expectations and ensure efforts are focused on key areas.
• External Vendor Data: As well as referencing the Data Transfer specification developed for each vendor, the frequency of transfers, key contacts, and agreed process for receipt of unblinded data should be included.
• Paper, Electronic or Hybrid Study Format: Ensuring that all processes are looked at in view of the complete data collection strategy, i.e., if data is to be entered from paper questionnaires into the EDC system is a cross-check needed between the eCRF and questionnaires.
• EDC/Database for Data Collection: Key features of the EDC/Database base should be included: Languages, user roles, version, etc. Including the version will help explain the lack of a certain functionality if a newer version is released and not adopted.
• Data Entry Process: The complete data entry process should be included, from receipt of a paper document to data entry. Details on how the data will be received, how soon the data will be entered, type of data entry (single/double), details of data entry QC to be performed, acceptable error rate. The transmittal form, Data entry report and other documents to be used for the process should be included in the DMP appendix.
• Data Items to be Coded: Including coding dictionaries and versions will be used, specifying if the same dictionary version will be maintained during the course of the study.
• Country/Site Specifics: Specifying the number of countries and sites taking part in the study, including any special considerations/process put in place for a country/site, e.g., initials not to be collected as per a country’s data protection laws.
• Expected Output Documents: To include under each section as relevant the document to be created for each task, including a template with the DMP appendix.
• Responsibilities: A table of responsibilities including function/role vendor should be included, ideally with start and end dates.

In conclusion, once the setup phase is complete and all specific study documents (e.g., Data Transfer Specification, Data Entry/EDC Completion Guidelines) are finalised, the DMP should serve as a comprehensive reference for the Data Manager. It should be regularly updated throughout the study to reflect key changes. Adhering to Good Clinical Practice (GCP) requires documenting all study activities, and the DMP, alongside the Data Management Report (DMR), provides evidence of initial plans and study outcomes.

Receive support on creating and developing your clinical data management plan

Quanticate’s Clinical Data Management team have extensive knowledge in managing data across Phases I-IV and medical device trials, and are dedicated to ensuring high quality clinical data, with a wealth of experience in data capture, processing and collection tools. If you would like more information on how we can assist your clinical trial with flexible and customised solutions, submit an RFI .

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