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



Email Alerts in Clinical Trials Improve Study Team Efficiency

Look what assisTek can do to help your study team manage compliance, undesirable events, site visits, etc more effectively and proactively! 

 Patient Non-Compliant?

  • Email alert directly to Study Team for follow-up.
  • Email reminder sent directly to patient to complete diary entry.


Nurse Records AE?

  • Email alert directly to Investigator for Review and Assessment.


Patient records undesirable symptom, event, medication, etc?

  • Email alert directly to Study Team for review and follow-up.


Site Visit coming up?

  • Email reminder sent directly to patient.


When used correctly, email alerts can help study teams manage critical issues more efficiently, and help gain compliance from patients before it’s a problem.

assisTek’s email alert system is linked directly to specific events based on protocol requirements and study team needs.

Questions about how this can work in your study? Find out more:  (and yes we do reply!)



Electronic Adverse Event Reporting and Follow-up

Patient safety has never been more important than it is today in Clinical Trials.

assisTek has built an infrastructure to support the collection of patient and clinician reported adverse events, all electronically.  Emphasis has been placed on what matters most – accurate and timely reporting of symptoms, proper notification to the study team and immediate access to data.

Two relevant examples of how symptoms are captured, team members are notified, and data is updated are below:

Patient eDiary Example:  Patient reports potential Adverse Events from home, Study Team is instantly notified and has access to data for follow-up & updates.

Direct Clinical Data Capture Example:  Clinician collects Adverse Events from patient, Investigator is instantly notified and has access to data for follow-up & updates.

Contact assisTek to understand how your study can benefit. (and yes, we will reply!)

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Patient Engagement in Clinical Trials

Video below

As studies get longer, and patients are expected to collect study data independently from home, patient engagement and retention has become a key concern for sponsors.  For example, in a recent study, patients were asked to keep their diaries for two years!  The sponsor tasked assisTek with creating new and engaging features to keep the patients active with the eDiary and maintain high rates of compliance.  The results were a success.  Patients have access to weekly sponsor newsletters relating to their therapeutic area, and also have a few fun games to play at any time; they are definitely engaged!

New technology used for Patient eDiaries has been leveraged to create opportunities to engage patients and keep them interested and involved in their clinical trial. The benefits of keeping patients engaged are significant to study teams in many ways:

  • Higher quality data
  • More consistent data
  • Increased compliance
  • Less recruiting to replace patients who leave study or are non-compliant
  • Lower burden on study team to follow-up with borderline patients
  • Happier patients = Happier study team

Depending on the age of the subject, and the therapeutic area, assisTek has created many engagement techniques that are working effectively in clinical trials around the globe.

  • Newsletters and Videos:  Periodically, the sponsor will create a newsletter and/or video relating to the study or therapeutic area.   The content will then automatically be installed on the patient’s device, remotely.   The patients look forward to turning on their eDiary and seeing messages from the Sponsor.
  • Trivia and Games:  Trivia and games are used to engage patients on a day-to-day basis.  assisTek has created games & trivia that are geared towards specific age populations.  For example, Sudoku might appeal to the baby-boomers, while Trivia may appeal to the retired population.  Either way, the sponsor can keep patients even more engaged by giving them rewards at site visits for answering questions correctly.  The goal is to maintain interest in the study and the data collection tool; which will translate into higher compliance rates.
  • Study Progress Calendar:  A patient’s progress in a study is important to them.  Patients want to understand how far they’ve come, they want to see what is in their future, and they want to feel connected to the study in which they are participating.  assisTek has many ways of achieving this.  For example, an eDiary can include a screen that displays how many days left a patient has left in the trial, and what their compliance has been to date.  Another option is to include a screen that displays the intervals for site visits, and other relevant appointments, as deemed by the sponsor.   Both examples offer a way to keep patients motivated and engaged in the study from start to finish.
  • Email and SMS Text:  Having a personal cell phone is almost guaranteed in every developed country around the world.  Since patients are likely to carry their personal cell phone with them the majority of the time, assisTek has developed solutions that will send SMS Text and Email reminders to subjects based on events entered (or not entered) on their eDiary.  For example, if a patient has not recorded their daily report on the eDiary, they could receive a text message reminding them to complete before a certain time.  This tool is invaluable if high compliance rates are expected from patients.

There are countless reasons to make a conscious effort to keep patients engaged in a study.  It benefits the sponsor significantly to have a high compliance and retention rate. The best way to achieve this is to motivate patients through proven engagement techniques and features.  assisTek is chartering this critical segment of clinical trials.  To understand more, or to schedule a demo, please email