The Beginner’s Guide To CRA Source Data Review and ALCOA in Clinical Research
A Clinical Research Associate (CRA) is a liaison between the site and sponsor, dedicated to focusing on the needs of both to be able to give feedback and provide suggestions while maintaining Good Clinical Practices (GCP’s). As a CRA, it is imperative that before anything occurs, a great working relationship is created with the site in order to eliminate any fear of communication and become more efficient as well as productive. This will encourage the site to ask questions and verify certain statements that the protocol or sponsor may be ambiguous about, therefore, eliminating any unnecessary errors and/or deviations and keeping surprises during Interim Monitoring Visits (IMV’s) to a minimum. Establishing this kind of relationship will prevent resistance and help to nurture the success of the site, the CRA, and ultimately the goals of the Sponsor. With that being stated, source documents can be discussed.
A Source document is to be considered any data, document, or record created and/or collected as the first point of data entry during the course of a clinical trial. One of the main objectives of a CRA is to provide quality assurance to the sponsor, this requires the ability to thoroughly verify the Source Documents of a trial during an IMV or sometimes via Remote Monitoring Visit (RMV). In order to be adequately accomplished, there are five principles known as ALCOA: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) for the proper verification of source documents to ensure data integrity, validity, and subject safety among other aspects.
Attributable, is the first principle of ALCOA pertaining to who is responsible and for which data point collections. The Delegation of Duties Log, will do as titled, it specifies which duties are delegated to who and the tasks listed must be appropriate to the individuals’ education, training and/or experience. All personnel performing any study specific tasks must be listed with the PI signing off on all delegated roles. The PI will also sign off on any dates that any given personnel stop performing tasks at the site and/or seize participation as an investigator for that trial. Delegation logs require information such as: name, role(s), start/end date(s), signatures, initials and tasks assigned. A CRA will utilize this log as a tool when performing verification of data.
The second principle is Legibility, this is extremely important because if data is unreadable, then it is useless and raises concern as to what data point is being overlooked or unchecked. When a mistake is made or something is not legible, it should be corrected by striking it through with one line, re-writing it, then noting the correction with initial and date. This should be performed in real time immediately after the error or during discovery of an error. Using whiteout or blinding an error is not an acceptable form of correction and should be avoided in order to maintain transparency. If this is found, typically it will not be malicious but as a CRA, it would be wise to train and/or educate a site of the aforementioned so that the errors are not misinterpreted.
Contemporaneous is the third principle and demonstrates that collected data should be existing, occurring, or originating during the same time. Data can only be assumed credible, if it is recorded and documented at the time of which a measurement or action is taken. All of the sources for a given subject must correspond, creating a story that should flow and make sense raising no doubt or leaving unanswered questions. If data is not collected in this way, there may be bigger concerns to be wary of, such as fraud, and ultimately would lead one to suspect that the integrity of the data may have been compromised.
The fourth principle of ALCOA is Original. Any item on which a data point is collected, no matter what was used to record the data, is now the original source document and should be included in the subject source as the source for that data point. It is not recommended to collect data on random items, a site should have standard operating procedures detailing exactly how data is to be recorded, but these things may occur. It is important that original data is not transcribed to another source document in order to prevent errors being created during the transcription due to misinterpretation. Action by the CRA should be taken so that the site is aware of avoiding capturing data in this way, and that it is secured along with the corresponding sources.
Accuracy, is the fifth and final principle and typically requires discretion and data trending by the CRA if alarming inconsistencies are discovered. All aspects of the data should be taken into account while investigating inconsistencies, such as use of different pieces of equipment or procedures/assessments performed by different personnel. At this point, asking whoever performed the task is usually the best option as it will give the CRA insight on details of how the inconsistency may have occurred.