eSolutions to Meet FDA Requirements to Maintain Adequate Records (Part 4 of 6)

This post is Part 4 of a 6 part series. Visit weekly or enter your email to subscribe.

Electronic diary solutions are typically customized software programs built with rules and edit checks that can track compliance, facilitate efficiencies and significantly reduce queries. Electronic boundary and edit checks should be used to minimize errors and omissions at the time of data entry. Additionally, an eDiary solution can include a subject dosing screen to capture required investigational product administration as well as software customization to prompt the subjects to complete missing data before allowing them to move from one question or screen to the next. Electronic diaries can include fields to “record storage temperatures of study medication that was stored in subjects’ refrigerators”1 in compliance with storage condition requirements specified by the protocol. Likewise, drug administration screens can be linked to drug inventory management systems to meet the FDA requirement to maintain adequate records of the disposition of the investigational drug (21 CFR §312.62(a)).

When implementing electronic edit checks, user acceptance testing should be a priority to ensure business logic and protocol driven rules fit the purpose, prevent duplicate entry, make sense to the user and do not conflict. For example, it would be confusing for a patient who identifies himself in the eDiary as male to be asked about his pregnancy status. Data elements that are captured more than once should auto populate when the data is static (i.e. date of birth), but require a new entry for data expected to change (i.e. weight). Electronic triggers should be tested to avoid conflict and verify missing or out of range data. Device logic that requires the patient to answer a question about climbing stairs before moving on to the next question should have an option to indicate a reason for leaving the question blank. In this example, the patient may be in a wheelchair, or may not have climbed any stairs in the applicable timeframe for the interval questionnaire. In another example, an electronic rule that requires the patient to complete a “visit 2” diary before allowing access to “visit 3” diary data entry could be problematic when the patient may have missed or skipped their second visit or the allowable time window to enter the visit 2 information. Sponsors should include information on electronic prompts, flags, and data quality checks that are designed to address data inconsistencies, missing data, and entries out of range in their data management plan so that it is available for FDA inspection.2

to be continued…

1 FDA Warning Letter Ref. No. 06-HFD-45-11. Retrieved October 25, 2012 at

2 Guidance for Industry Electronic Source Documentation in Clinical Investigations Draft Guidance. U. S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner. November 2012. Retrieved December 18, 2012 at