• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA: Data Management Plans Key for Trials

FDA: Data Management Plans Key for Trials

October 29, 2018
James Miessler

Clinical data management plans aren’t mentioned in FDA regulations, but don’t be fooled – they’re a key ingredient in winning product approval. So don’t just shrug them off, says a top agency official.

“Please don’t say ‘It’s not in the regulations, I don’t need to do it,’ because at the end of the day, if you don’t have that good data, your product is not going to be approved,” Cynthia Kleppinger, CDER’s senior medical officer, cautioned last week at a joint FDA-MHRA workshop on data integrity in global clinical trials.

Data management plans – strategies for more effectively and efficiently achieving high-quality, statistically sound, reliable data – aren’t just set aside after they’re drawn up; they’re considered “living documents” throughout the lifespan of clinical trials, she noted.

Sponsors should assign responsibilities, with data management plans detailing who will be writing, reviewing, approving and finalizing them, and how they will be modified, if necessary, during projects.

Kleppinger emphasized that data management plans aren’t isolated documents—and should “never stand alone.” They should link to numerous SOPs – and tie together many elements, including the design plan for case report forms (CRFs) and a CRF tracking system to ensure that the required CRFs are gathered.

Data security measures in clinical trials, such as data backup and access restrictions, should be mentioned, as well as a list of what sponsors need to do before database lock . Conditions for database unlocking – which should only be for critical issues – should also be described in the plan.

Plans should include data extraction tools, such as electronic health records and recording devices, too. While the devices are “more and more being pulled into… clinical trials,” sponsors should understand they weren’t intended for clinical research, Kleppinger noted.

Sponsors should also tie in external data (such as off-site lab and imaging data), quality assurance and quality control (auditing and monitoring activities), how they deal with discrepancies and how they will generate both standard and custom reports.

“You’re looking at a quality system, so you should hopefully be generating reports that are also looking at how the trial’s going, and if there are any issues that are developing,” Kleppinger explained.

Sponsors should be especially wary of certain potential pitfalls such as poor case report form design, not addressing missing data before it goes missing, site and monitoring issues, and not involving appropriate staff members.

Kleppinger urged sponsors to “have some prompts, some flags and quality checks to address any sort of data inconsistencies, missing data, etc.” in their plans – and to refrain from having sites do calculations to enter their data. “There are a lot of errors noted,” she warned, adding they should craft separate validation plans, which are frequently requested during FDA inspections, as a backstop.

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing