Webinar: eSource in Clinical Trials, Pros/Cons & Lessons Learned from Phase III Clinical Trials

For those of you who missed the eSource Webinar hosted by assisTek on April 4, 2013, you can still watch the entire Webinar on video below!

Description

This webinar will focus on Real-Life examples of ongoing Phase III global clinical trials using mobile Direct Clinical Data Capture (eSource) solutions. Topics discussed will include:
- Overcoming data quality and data access problems that plague studies using the traditional paper transcribed to EDC process.
- Supporting site workflow with eSource
- Cost Savings Model (Query Reduction & Elimination of SDV)
- Impact and Integration with external clinical databases (EDC, etc)

 Please contact Evonne Roberts, evonne.roberts@assisTek.com with any questions or to schedule an on-site demonstration.

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FREE WEBINAR: eSource in Clinical Trials: Pros/Cons & Lessons Learned from Phase III Global Studies

Join assisTek for a free webinar!  Details below:

Description

This webinar will focus on Real-Life examples of ongoing Phase III global clinical trials using mobile Direct Clinical Data Capture (eSource) solutions. Topics discussed will include:
- Overcoming data quality and data access problems that plague studies using the traditional paper transcribed to EDC process.
- Supporting site workflow with eSource
- Cost Savings Model (Query Reduction & Elimination of SDV)
- Impact and Integration with external clinical databases (EDC, etc)

Date and Time

Thu, Apr 4, 2013 10:00 AM – 11:00 AM MST

Register
https://attendee.gotowebinar.com/register/2003721752268355328

Questions?

Contact Evonne Roberts, evonne.roberts@assistek.com, 480-874-9400 x. 336

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

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

FDA “… recommends that clinical data be entered electronically by study site personnel at the time of the subject visit to avoid transcription from unnecessary paper records1. The acronym “ALCOA” is frequently used in reference to best practices related to source documentation. When eSource solutions are selected and developed appropriately, data is attributable to a unique user with a secure password and role-specific privileges; legible in a clean and easy to read standardized format; and contemporaneous with a date and time stamp for every entry/edit/modification. Original records initially captured electronically can include direct entry of clinical data into a study database, data transmitted from an electronic health record, and electronic diary data entered by a subject or transmitted from an automated instrument that captures a biological result. eSource provides the opportunity to engineer accurate data with boundary and edit checks for missing and/or out of range data devoid of contradicting information often represented by subjective reporting in an unstructured format.

To minimize risks related to FDA requirements to keep accurate records and protect human subjects, sponsors using electronic source solutions should keep records of:

  • system validation and maintenance,
  • system specifications showing customization to fit the eSource for the purpose of the study,
  • 21 CFR § 11 compliance and
  • data integrity practices.

Ultimately, the same system development collaboration and documentation intended to manage risk, will have the added benefits of quality design, validated performance and accurate data capture with electronic efficiencies that reduce data noise, facilitate analysis and expedite time to data lock…and that’s what is best for patients.

eSource Best Practices
1Guidance 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. December 2010. Retrieved October 23, 2012 at http://www.fda.gov/downloads/Drugs/…/Guidances/UCM239052.pdf

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eSolutions to Meet FDA Requirements to Maintain Adequate Records (Part 5 of 6)

This post is Part 5 of a 6 part series. Visit weekly or enter your email to subscribe.

FDA guidance suggests sponsors should include information about the intended use of computerized systems in their data management plan. Compliant with 21 CFR part 11, this data management plan should also describe the “security measures employed to protect the data and a description of the flow of electronic data”1. In the workflow demonstrated in the Figure below, note that a unique user name and password is required to access the system. Each user is associated with a user group and each user group is limited to specific roles/functions within the eSource. The user activity is date and time stamped in real time and an audit trail serves as the automated documentation of who did what, to whom and when.

Figure 3 

eSource systems/vendors should:

  • support controlled and secure access typically by
    • a username/ ID and password,
    • user roles,
    • role-specific privileges,
    • data encryption, and
    • workflow
  • create and maintain an audit trail of data entry and data revisions including
    • the “old” value,
    • the “new” value,
    • date and time stamp,
    • and the user who entered/changed the data
    • reason for the data edit
  • have a provision for data transfer and storage for the time required by the regulations

to be continued…

1 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 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf

 

 

 

 

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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 http://www.fda.gov/ICEPI/EnforcementActions/WarningLetters/2007/ucm245744.htm

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 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf

 

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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:  info@assistek.com  (and yes we do reply!)

 

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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.

Emailinfo@assisTek.com (and yes, we will reply!)

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