Providing training to subjects and caregivers on their responsibilities in a clinical study and guidance on how to complete an electronic questionnaire play an important role in patient- and observer-reported outcomes.It’s no surprise that global regulators are increasingly commenting on the importance of training these raters to ensure high quality data collection.Here, we review current guidances and how providing training via the same electronic devices that will be used for study data collection can help sponsors meet regulators’ expectations.
Training can be mapped to the FDA PRO Guidance which states that, “Results obtained using a PRO instrument can vary according to the instructions given to patients or the training given to the interviewer or persons supervising PRO data collection.The quality of a clinical trial can be optimized at the design stage by specifying in the protocol procedures to minimize inconsistencies in trial conduct.We recommend:Training and instructions to patients for self-administered PRO instruments.Interviewer training and interview format for PRO instruments administered in an interview format.”1
In addition, FDA 21 CFR 11 recommends that, “Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.” 2
Training can also be mapped to FDA Guidance for Industry:Electronic Source Data in Clinical Investigations which states that, “Source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA)”.3
To be Attributable, it should be clear who created a data record and when.Data gathered from an eCOA device is date and time stamped with unique user identification, providing an electronic audit trail.When training and quizzing are provided on the electronic device, an audit trail is also provided, as well as a record of training compliance.
To be considered Legible, the data need to be clear enough to read and recorded in a permanent medium (not pencil).If the data are illegible, they cannot be used.Electronic data solves this problem easily.When questionnaires, as well as training quizzes are provided electronically and subjects/caregivers select responses rather than write them, there is no question as to legibility.
To be Contemporaneous, data should be recorded as events happen – no predating, postdating, or trying to recall information from memory.This is another advantage of gathering data electronically.When a subject/caregiver completes a training quiz or a study-related questionnaire on an electronic device their answers are captured in real-time with automatic date and time stamps.
To be considered Original, source data is required.When the first record is electronic, an audit trail is started.If study compliance begins to drop, by looking at the date the subject/caregiver first completed the training and quiz, remediation can be recommended or forced through the electronic device.
To be considered Accurate, it’s critical that the source data reflect true observations.The data need to be honest and thorough.Collecting training compliance and quiz data electronically provides a level of transparency and helps to prevent data from being altered.
Additionally, the EMA’s “Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials” recommends utilization of ALCOA and adds the following 4 elements:Complete, Consistent, Enduring and Available (CCEA) when needed.Completeness and Consistency are defined as, “Completeness and consistency:can be assisted by the use of features such as drop-down lists, online edits, check boxes and branching of questions or data entry fields based on entries.The individual (investigator site staff, study subjects, caregivers or others) capturing the data needs to have documented training in the correct use of the instrument and the electronic data capture document.”4 Conducting subject and caregiver training electronically helps sponsors to meet these requirements and comply with EMA regulations.
An effective training strategy meets regulators’ increasing requirements for training sites, subjects and caregivers on their role and expectations in clinical studies and helps to meet existing ALCOA/(CCEA) standards for electronic source data during clinical development. Further, sponsors who provide electronic training via the same devices that will be used for study data collection benefit from reduced rater bias and unnecessary data variance, resulting in improved data reliability.
For more information on providing effective subject and caregiver assessment training during clinical development, read “The impact of rater training on clinical outcomes assessment data:a literature review.”
June Tuller, MS, is the Lead Rater Training Developer at ERT.
- U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH).Guidance for industry.Patient-reported outcome measures:use in medical product development to support labeling claims.2009, Food and Drug Administration:Maryland.
- US Food and Drug Association.CFR – Code of Federal Regulations Title 21.April 1, 2016.Retrieved August 12, 2016 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=11.10
- FDA Guidance for Industry Electronic Source Data in Clinical Investigations (Sept. 2013) retrieved from https://goo.gl/kttbyu
- European Medicines Agency.Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials.2010, European Medicines Agency:United Kingdom.