Page 17 - Research Compliance Welcome Package

Documentation Standards
(commonly referred to as “ALCOA”)
Attributable - Is it traceable to the person who observed and recorded it?
Legible - Is it readable by others and recorded in a permanent medium?
Contemporaneous - Was it promptly recorded in a permanent medium?
Original - Is it the initial record of activities and observations?
Accurate - Is the information without errors (or with errors that were appropriately corrected)?
References:
ICH GCP E6
• 1.51 - Source Data
• 1.52 - Source Documents
• 2.10 - Principles of GCP
• 4.6.3 - Investigational Product
• 4.8 - Informed Consent
• 4.9 - Records and Reports
• 8.3.13 - Source Documents
FDA
• FormFDA1572-Commitments
• 21CFR312.62(b)-Case
Histories
• 21CFR812.140-Records
Among FDA Top Inspectional Observations:
Failure to prepare/maintain adequate/accurate case histories with respect to observations and data pertinent to the investigation or informed consent...
ISSUE
09 JUNE 2018
In this issue:
Eligibility Checklists P.2 Spotlight on Privacy P.3 Ask the Auditor P.3 Trend Watch P.3 Mad Lib Contest Winners P.4
Good Documentation Practices
What would happen if the Food and Drug Administration (FDA) contacted our site to schedule an inspection of one of our research projects and the staff who conducted the study were no longer at BSWH? Would FDA track down the former study personnel to ask them questions before initiating their inspection? No. They would expect the data and documentation to accurately reflect what occurred at our site. Successful outcomes of inspections heavily depend on the documentation practices of the personnel that worked on the project. Good documentation in research independently tells the story of what happened during the conduct of the research and ideally creates an audit trail for reconstructing the who, what, when, where, how, and why of events. Here are some important reminders to keep in mind as soon as you start a study to allow the research record to stand alone:
• Make recordkeeping a top priority throughout your day. Timely documentation allows you to more accurately recall details and stay prepared for an audit.
• Maintain clear documentation for every pertinent event, including communications with the subject and sponsor which may explain such events as deviations from the approved protocol or standard procedures.
• Checklists may need supporting detail beyond a simple checkmark (e.g., the checklist may end up being the sole source document for a particular study requirement).
• Many projects involve multiple study personnel who are responsible for documentation, so remember to have everyone document for him or herself.
• A Delegation of Authority Log (DAL) may need to be referenced for handwriting samples from specific study personnel. This is especially important because source documents may only be initialed if an appropriate DAL documents staff initials—otherwise, they must be signed and dated.
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