Good Clinical Practice Study Documentation

The Department of Medicine Clinical Research Unit has prepared this document is to provide guidance to all faculty and staff involved in the conduct of research on the best practices related to documentation.

Good study documentation will allow for an individual with basic knowledge of the particular project to recreate the events of the study.

General Information

  • Maintain records of all data and observations pertinent to the research subject.  These records should be identifiable to a particular participant.
  • Remember that source documents are where the information is first recorded.
  • All data must be verifiable.
  • Study documentation should be able to recreate the study for any reviewer.
  • Apply the ALCOA acronym for proper technique of documentation:
    • Attributable – Can you tell who wrote and/or did this
    • Legible – Can it be read?
    • Contemporaneous- – Is the data current, and in the correct time frame?  The notation, signature and date should occur at the same time.
    • Original – Has the data been altered?
    • Accurate – Are there conflicting data elsewhere?  Content should precisely reflect the event.
  • Use a signed Note to File to explain any discrepancies, missing or incomplete data.

Standards

  • The same standards maintained for medical documentation should be followed for research documentation
  • All documents require 2 identifiers on each page. 
  • All entries are to be signed and dated in real time.
  • Error corrections are made by drawing a single line through the incorrect entry, initial and date.
  • Never obliterate entries that require correction.
  • Subject records need to be secure but accessible.
  • Do not alter past-dated notes by writing alongside or adding to prior entries.  Updates may be made through addenda.
  • Use dark ink, do not use pencil.
  • Never use whiteout.

Addenda

  • If the source data is incomplete or deficient, it may be completed or corrected using an addendum.  This late entry must be signed and dated at the time it is created.

Note to File

  • May be used to correct errors, or as an explanation to a departure from the protocol.  Reasons for any departure should be documented and attempts to correct or prevent in the future should be included.
  • This should not be used as a panacea to correct any error.

Informed Consent

  • The process requires documentation and should reflect the process approved by the IRB in a narrative form or through the use of a checklist.
  • Signature and date and time must be of the person obtaining the consent, at the time of the process. (Not added later)

Case Report Forms as Source

  • Case report forms may be used as source only when this practice is clearly outlined in the protocol, and they represent the data collected for the research are where the data were initially recorded.    

Medical Records From Outside Source

  • Copies of records from an outside source may be used if they support endpoints, inclusion/exclusion criteria or adverse events.
  • Attempts to obtain medical records should be recorded in the research chart.

Questionnaires

  • Documentation must reflect who completed the questionnaire, in compliance with the protocol.
  • For questionnaires completed by staff, a note should reflect how the information was obtained ie: direct interview with participant, phone call, chart abstraction.