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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.