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Mastering Data Integrity & Documentation

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In the world of clinical research and FDA inspections, documentation is more than just a regulatory requirement—it is the backbone of compliance, transparency, and credibility. Inaccurate or incomplete records can jeopardize studies, lead to regulatory findings, and erode trust with sponsors and regulatory agencies. Whether you’re managing clinical trials, conducting audits, or preparing for an FDA inspection, strong documentation practices ensure that your data tells a clear, verifiable story.

Why Data Integrity Matters

Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle. In clinical research, this means ensuring that all collected data—whether from patient records, electronic case report forms (eCRFs), or lab results—is authentic, attributable, legible, contemporaneous, original, and accurate (commonly known as ALCOA+ principles).

Regulatory agencies, including the FDA, the European Medicines Agency (EMA), and the International Council for Harmonisation (ICH), expect organizations to maintain high standards for data integrity. Any missing, altered, or misrepresented information can lead to compliance violations, study delays, and even regulatory sanctions.

Common Pitfalls in Documentation

Even the most experienced professionals can fall into documentation traps. Some of the most common issues include:

  • Lack of version control: Failing to track changes in protocols or data records can result in discrepancies.
  • Incomplete or missing source documents: Investigators and site staff may overlook recording critical details, leaving gaps in study data.
  • Delayed data entry: Recording study data late increases the risk of errors, inconsistencies, and missing information.
  • Inadequate training: Staff unfamiliar with GCP-compliant documentation practices may unintentionally introduce errors.
  • Poor audit trails: Failure to document changes properly can raise concerns about data integrity and increase regulatory scrutiny.

Best Practices for Stronger Documentation

To enhance your documentation practices and maintain compliance, implement these strategies:

1. Standardize Your Documentation Procedures

Develop Standard Operating Procedures (SOPs) outlining how data should be recorded, reviewed, and stored. SOPs help ensure consistency across teams and reduce the likelihood of documentation errors.

2. Implement Version Control

Use electronic systems or document management software to track changes in study protocols, data entries, and training records. This ensures that only the most current and accurate versions of documents are being used.

3. Emphasize Real-Time Data Entry

Encourage teams to record data immediately after an event occurs. This prevents errors caused by forgetfulness or misinterpretation of past events. The FDA and other regulatory bodies prioritize real-time data capture as a critical element of compliance.

4. Utilize Digital Documentation Tools

Leverage electronic systems for secure data entry, validation, and storage. Electronic Trial Master Files (eTMFs) and cloud-based platforms ensure that documents are easily accessible, trackable, and protected from unauthorized edits.

5. Conduct Internal Audits and Inspections

Perform regular self-audits to identify potential documentation gaps before an official inspection occurs. Implement mock inspections to simulate FDA audits and prepare teams for real-world compliance assessments.

6. Prioritize Staff Training and Accountability

Provide continuous training on GCP-compliant documentation practices to ensure that every team member understands their role in maintaining data integrity. Staff should be able to confidently explain their documentation processes during an audit.

Final Thought: Are You Ready for an FDA Inspection?

If an FDA inspector walked in today, would your documentation hold up? Would your data tell a clear, verifiable story? Preparation is key, and strong documentation is your first line of defense.

As part of our commitment to keeping you informed, we’ll continue sharing actionable insights, regulatory updates, and compliance strategies to support your success.

Thank you for being part of our community—stay compliant, stay confident, and document everything!

Source Documentation: “May the SOURCE Be with You…”

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Lack of consistent, clear, and adequate source documentation is one of the most typical inspection results in investigator site inspections. This is also the most discovered flaw during sponsor audits. To guarantee that the study results are established on the foundation of trustworthy and legitimate data, investigator sites must be reminded of the need for good documentation practices. 

The origins of excellent documentation standards can be found in the (International Conference of Harmonizaton – Good Clinical Practice) ICH-GCP, which defines source data and source documents. 

 ICH E6 1.51 source data 

This includes all original documents and authenticated copies of original records of clinical results, observations, or other activities in a clinical trial that are required for the trial’s restoration and assessment. The documents containing source data are referred to as sources. 

ICH E6 1.52 source documents 

This includes original documents, data, and records such as hospital records, clinical and office charts.  The ALCOA-C acronym (attributable, legible, contemporaneous, original, accurate and complete) was coined by the US Food and Drug Administration to describe key characteristics of acceptable documentation. The World Health Organization has also adopted these. These requirements have changed over time. More ‘letters’ have been added by the EMA to indicate features of good source documentation, particularly for computerized systems. 

 Common Findings Associated with Source Documentation 

Following are the common findings associated with source documentation: 

  1.  It was not possible to validate the eligibility criteria. 
  2. Because there were multiple entries for the same data point, it was impossible to tell which one was the correct source record. 
  3. Inconsistencies in records were used to corroborate the study’s primary effectiveness outcome. 
  4. Abnormal lab values were not indicated on lab reports nor any contradicting material gathered in source documentation have been shown clinical importance. 
  5. Missing pieces of information from subject interview scales, a slew of unexplained revisions months after the initial entries, and contradictory data; erroneous subject identification, inaccurate date were identified. 
  6. Factually inaccurate paperwork regarding drug disposition—dates, amount, and subject use were found.  

How Can Documentation Be Improved? 

Documentation can be improved by the following ways:

  • Give PI the responsibility to assign tasks to the trained staff. 
  • Commitment and continuous presence must be acknowledged by the Principal Investigator (PI) throughout the study. 
  • Sites conducting the study must prepare SOPs which ought to be shared with the Contract Research Organization (CRO) or study sponsor. 
  • All technical aspects must be clear of confusions and errors prior to starting work on any study.
  • The sponsor and/or the CRO ensure PI’s commitment to the study.  

 Conclusion 

The ALCOA-C and other properties indicated by regulatory agencies and GCP should be demonstrated in source documents. During regular audits, the most frequently stated findings are those linked to source documentation. The PI’s dedication to the trial and participation in it makes a tremendous difference. Efforts to educate sites, understand their practices from the pre-study visit onwards, and to monitor and train them on a regular basis will all aid in increasing and sustaining the quality of site source documentation procedures. 

 

References 

“ALCOA”: Elements of good documentation. (n.d.). Retrieved October 24, 2021, from https://blink.ucsd.edu/research/policies-compliance-ethics/compliance/ALCOA-Standards-210304.pdf. 

Bargaje, C. (2011, April). Good documentation practice in clinical research. Perspectives in clinical research. Retrieved October 24, 2021, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121265/. 

Commissioner, O. of the. (n.d.). List – ich guidance documents. U.S. Food and Drug Administration. Retrieved October 24, 2021, from https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents. 

GLP documentation. (2007). Good Laboratory Practice Regulations, 241–258. https://doi.org/10.3109/9780849375842-11  

 

 

Our Mission and Purpose

The mission of 2K Clinical Consulting, Inc. is to ease the burden of GxP compliance and to transform the effectiveness of professionals and compliance systems worldwide.

Our History

2K Clinical Consulting, Inc. is the vision of former FDA Investigator, Kimberly Kiner, who empathized with facilities and sites that struggled with understanding and complying with regulations. After years in the field, Kimberly transitioned into the private sector and acquired international experience in compliance, monitoring and study management while she worked for pharmaceutical and invitro/medical device companies as well as CROs. This work experience is what sparked her desire to work as a consultant for organizations such as the Association for Clinical Research Professionals and the Society of Clinical Research Associates. Kimberly later went on to train providers such as Compliance Online and Fx Conferences. This exposure became the gateway to connecting with other experts and teaching professionals resulting in an engaging experience for clients that closes the gap in best practices within the realm of compliance.