At the heart of a clinical trial is the relationship between the sponsor and the site at which the research occurs.
Trust between the sponsor, which could be a pharmaceutical company or biotech manufacturer, and the site—be it a private clinic, a lab, or possibly a clinic or lab at a research university—is paramount. The sponsor must feel certain that the clinical trials that their medication, therapeutic approach, or biomedical device will undergo will always adhere to Good Clinical Practices (GCP).
That way, the research sponsor can feel confident that the data collected in the course of the trial will be thorough, accurate, and complete. Any errors or inaccuracies in the research could mean the investment the sponsor has made in whatever product they hope to bring to market may never pay off.
But more important than that, the accuracy and success of these studies could affect the quality of life for countless people.
Stewarding the relationship between site and sponsor is the clinical research associate (CRA). And the primary tool a CRA uses to foster good standing between the sponsor and the research site is the source document. Moreover, it’s vitally important that the source document is developed and maintained following the five principles known as ALCOA.
What Is a Source Document in Clinical Research?
Before defining ALCOA and the important role these principles play in the process of clinical research, it’s important to understand the source document, developed in part by the clinical research associate.
A source document can take many forms, but in the context of clinical research, the original source document must accomplish the following:
- It must prove the existence of study participants.
- And substantiate and verify the accuracy of the data gathered during the trial.
The source document is the first point of data entry in a clinical trial and is often shared with the sponsor both in person or through some form of remote sharing. In order for the clinical research source document to accomplish the above-mentioned objectives, it must be developed following the principles of ALCOA: Attributable, Legibility, Contemporaneous, Original, Accuracy.
The first principle that a source document must follow is that everything contained within the document must be attributable. This is accomplished through the delegation of duties log.
Not only will the delegation of duties log act as a record of who did what in the course of the trial, but it will also track their education, training, and experience. Furthermore, it’s all checked and signed-off on by the PI, or principal investigator, a leadership role in the process of clinical research.
To this end, the delegation of duties log will always include the following information:
- The role, or roles, performed
- The start and end date of the duties
- Initials and signatures
All of this plays an important part in verifying the authenticity of data gathered during the trial, both by the CRA and the sponsor of the research.
The L in ALCOA stands for legibility. Perhaps logically, all data recorded in the source document must be legible. In addition, any errors that do occur in the source document must be corrected in a specific manner: by striking through the error, with the initials and date that the correction occurred.
All corrections should be made the correct away, ideally in real-time once the error is discovered. Whiting out the error is not an acceptable form of correction. Since this is vitally important, all CRAs should be trained in appropriate ways to maintain legibility and correct any errors that may occur in the development of the primary source document.
It’s also important that all data recorded in the primary source document is contemporaneous, or that it can be verified that the data was recorded at the time the testing took place. In addition, the data must flow logically and make sense: that step B occurred after step A and before step C, for example, and that the data is logged to reflect that sequence of events.
Any discrepancies in this regard can cast the validity of the whole trial in doubt, and, in some extreme scenarios, even lead to suspicion of fraud.
It’s also important that all data recorded in the source document must be original. This means, perhaps naturally, that not only should the data recorded in the source document be original to the trial in question but also that what is put down in the log is recorded by the clinical research associate that performed the task at the time it was performed.
A quality research site will have a standard operating procedure in this regard. Primarily, data recorded in the log should never be transcribed from another source, which creates the opportunity for errors to arise, nor should extemporaneous data be included in the log.
What should be recorded is the following:
- The step of the trial
- Who performed the task involved in that step
- When it was performed
- Any data collected
The last and final A in ALCOA stands for accuracy, and any inconsistencies or suspicion of inconsistency in the data must be immediately investigated by the CRA. Suspicion of inconsistencies generally arises when findings contradict the general data trend to an alarming extent.
The process of checking the data accuracy by a CRA generally involves following the trail maintained in the attributable part of ALCOA: finding who performed the task, checking to make sure there was no inconsistency in equipment or that there were no issues in procedure or in the assessment of the data.
This all must be recorded in detail for later review by the sponsor of the trial.
The Role of ALCOA in Clinical Research
In the process of clinical research, it’s imperative that trust is maintained between the sponsor of the trial and the site where the data is being gathered. That relationship is developed and supported through the data’s primary source document.
That primary source document can take many forms and is often viewable in real-time by the sponsor of the trial. It’s also vitally important that all data recorded in the document follows the principles outlined by ALCOA:
That way, inconsistencies can be investigated by a CRA and confidence can be maintained between the sponsor and the clinical research site.
Understanding and adhering to ALCOA is an important part of the clinical research process. With this information, you’re well on your way to becoming a clinical research professional.