To run a successful clinical research organization, data integrity needs to be an essential part of any clinical trial. While maintaining GCP, clinical research sites also need to be sure that their source data follows FDA guidelines and standards for record keeping. Whether its electronic or paper source documentation, standards require that research sites follow ALOCA. But what does ALOCA stand for and what does that truly mean for your organization?
Attributable – To maintain good GCP, being able to prove where documents come from and who provided the information is extremely important. With an electronic record, being able to identify that information is easy; it can be tracked within the electronic system and can provide a clear path for changes and confirmation signatures. Keeping tracking of every written element can be slightly trickier when there are physical documents; your research organization will need signatures, dates and identifiers to maintain FDA standards. The most important aspect of the attributable portion of ALOCA is that the audit trails can clearly identify who created or modified records.
Legible – If your research site is still working with paper documents, making sure that every word is legible and easy to read is essential for proper documentation. Anything that is illegible makes it difficult to re-create events recorded during the study. Electronic records resolve this problem, presenting the data in a clear and standard format that is obviously legible to everyone.
Contemporaneous – Study data must be entered at the time the activity was performed, with date and time stamps to confirm. If you are using paper documents, make sure that everything is documented in real time, no pre- or post- dating is allowed. With electronic records, time and date stamps are automatic and are noted when every piece of data is entered, edited or modified in the system.
Original – Source data is the first place that the data is ever documented. Original data can even have been recorded on a scrap of paper; it is important to keep that scrap of paper with the study records. Paper source documents need to be preserved and kept in their original form. If your first record is electronic, an audit trail can keep track of changes that are eventually made.
Accurate – The most important aspect of data integrity is accuracy; it is critical that the source is completely accurate and reflect the true data from the study. This means an honest representation of the facts in the context of the trial. Research sites should minimize the number of transcriptions to reduce inaccurate data; having consistent system checks can ensure that data meets the validation checks.
Keeping ALCOA guidelines is a simple way for research organizations to follow FDA guidelines, and keep their clinical trial data secure to protect themselves and their patients.