Ongoing and Completed eSource Programs at Target Health and ICH E6(R2)
Target e*CTR® (eClinical Trial Record) is Target Health’s patented eSource solution fully integrated with Target e*CRF®. A de novo 510(k) was cleared in December 2015 that used direct data entry at the time of the office visit, and an NDA was submitted to FDA with 7 studies which all used Target e*CTR. There were no FDA inspection findings in any of these programs. Ongoing studies include a large pivotal trial in Autism, a phase 2 study in dermatology and a device study. A new study in psychiatry will start in Q2 2017 as well as several other programs. Recently, a phase 2 study in neurology was completed with 900 subjects at 40 clinical sites. Completed programs include ADHD, urology, and phase 1 studies.
As part of the ICH E6(R2), sections were modified to address electronic records and associated roles and responsibilities. Target Health Inc. congratulates our colleagues at ICH who clarified the acceptance of electronic records as original records in lieu of a requirement to have paper source records.
The following are some highlights of the revisions as they relate to electronic records. Also refer to a paper recently authored by Mitchel and Helfgott, published on 4 January 2017 in Applied Clinical Trials entitled, Regulatory Considerations when Designing and Running 21st Century Paperless Clinical Trials.
Glossary: Certified Copy
A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original. (section 1.6.3)
Section 5. Sponsor
Record Access: The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection. (Section 5.15.1)
6.4 Trial Design
The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design, should include: The identification of any data to be recorded directly on the CRFs (i.e., no prior written or electronic record of data), and to be considered to be source data. (section 6.4.9)
8. Essential Documents for the Conduct of a Clinical Trial (Addendum)
The sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should provide for document identification, version history, search, and retrieval.
The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the sponsor. The sponsor should not have exclusive control of those data.
When a copy is used to replace an original document (e.g., source documents, CRF), the copy should fulfill the requirements for certified copies.
The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor