|PI Signatures Task Force|
The PI Signature task force is evaluating regulations and guidances that pertain to principal investigator signatures on study data and materials and will be making recommendations to the members of the eClinical Forum regarding issues surrounding different approaches to handling PI signatures. Workshops on this topic were held at the EU and NA Autumn meetings in October 2016. The group plans to present their findings to the eCF members at the eCF Global Spring meeting in Iceland in May 2017.
|Regulatory Expert Team|
The team provides expert evaluation of regulatory guidances from Europe, North America and Asia Pacific so that the impact on Clinical Research and eCF operations such as system criteria can be assessed. Consolidation of review comments via this group ensures that the eCF can respond efficiently to regulatory agency timetables for return of comments
|EDC HOSTING TASK FORCE|
In June 2013 representatives of the eClinical Forum participated in a meeting with the EMA GCP Inspectors working group (IWG) to discuss specific concerns, interpretation of requirements and possible solutions relating to data transcribed to electronic data collection tools in clinical trials and the requirement for investigators to keep a contemporaneous and independent copy of the eCRF. Key messages covered: a) The existence of a contemporaneous, independent copy of the eCRF under the exclusive control of the investigator is a requirement irrespective of the media used, b) The eCRF has to be considered as source even when data is transcribed from source records, c) Some of today’s EDC solutions may not completely address the regulatory requirements and the industry should move to compliance.
The eClinical Forum has now set up a task force to establish guidance and clarification as to how a trusted third party hosted web-based EDC system can provide a regulatory compliant solution. The scope of the project includes technical aspects of the solution, contractual arrangements and clarification of the tasks and responsibilities of the sponsor, investigators, the third party hosting provider and CROs. The EMA regulatory requirements for investigator control of transcribed data are the same as for electronic source data and those in turn are equivalent to FDA electronic source guidance, so the work of the task force has broad application and relevance. The group has now met with several regulators, including a meeting with the EMA IWG in Dec 2015, and continues this open dialogue.
|eSRA: A Project to Self-Evaluate the GCP Compliance of Systems Holding Source Data|
It is important that electronic health record systems (EHRS) that will supply source data for clinical research be designed and maintained to meet regulatory requirements. Sponsors ultimately bear the responsibility for ensuring that data harvested from these systems are acceptable, and investigators are frequently being asked to complete sponsor-specific assessments of their EHR systems. The eSRA project has developed a free tool that vendors and sites can use to help to quickly, easily evaluate their systems once for all sponsors, CROs, and regulators.
The eSRA (eSource-Readiness Assessment) tool was developed with extensive participation of global biopharma, CROs, technology providers, academia and with regulatory review.
The tool offers a series of questions based on FDA and EMA regulations and guidances, and provides suggestions on potential workarounds for areas that may fall short of regulatory expectations. A site can quickly identify if its system and/or processes are compliant with research regulations or if additional processes need to be put into place.
Using this assessment tool will enable sites to quickly provide the information needed by sponsors on GCP compliance of systems holding source data and will enable sponsors to evaluate and manage risk. Regulators and sponsors should feel confident in the quality of eSource coming from assessed sites. The eCF is currently in the process of designing an update to the tool that will include a more sophisticated interface and an interaction online questionaire. The eSRA tool can be accessed via www.eclinicalnetwork.org
|RISK-BASED APPROACHES: Best practices for ensuring clinical data quality|
Companies engaged in commercial clinical research have, since the introduction of formalized good clinical practices (GCP), adopted highly defensive practices around the monitoring of clinical trials. These processes have played a very large role in the high costs associated with clinical trials, without delivering commensurate value. Reasons are many, but surely include propagation of practices established during the years that trials relied on paper-based case report forms (CRFs), despite the fairly widespread adoption of electronic data capture (EDC) quite a few years ago. The reasons also include fear based on misunderstanding of regulatory requirements. All of this has resulted in the institutionalization of high cost, low value, manpower-intensive practices that do little to serve the interests of subject safety or quality data. Pharmaceutical, biotech, and medical device industries experiencing unprecedented economic upheaval can no longer afford the luxury of engaging in practices that deliver little value at exorbitant cost. Rather than continuing to spend time, energy, and money focusing on minutiae, e.g., the ability of site personnel to properly transcribe observations from one medium to another, those engaged in clinical trial conduct must re-focus their energies on the aspects of the clinical trial that matter most, such as protocol compliance, subject safety, data timeliness, and data integrity. Through the use of more up-to-date methodologies and technologies, companies can effectively address these concerns while saving both time and money. This paper addresses the regulatory and business rationales for adopting more rational monitoring-related tools and processes that, if implemented thoughtfully, should deliver higher-quality trial data, faster, and at significantly lower cost.
|EHR4CR: Re-use of Electronic Health Records for Clinical Research|
The eClinical Forum participates in the EHR4CR (Electronic Health Records for Clinical Research) project and is responsible for the development of scenarios for the platform and business model. This project was initiated in March 2011 under the Innovative Medicines Initiative which is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA. EHR4CR is one of the largest public-private partnerships aimed at providing adaptable, reusable and scalable solutions for re-using patient level data from Electronic Health Record systems for Clinical Research.
The EHR4CR platform and services will:
- Enable re-use of electronic health records to do better upfront protocol optimization and planning. Today… A third of protocol amendments are avoidable; over 40% of amendments occur before first patient first dose
- Provide tools for sites to identify candidates for clinical trials by electronically searching EHRs in order to improve patient recruitment which is one of the biggest challenges for clinical research.Today… 50% per cent of clinical trials fail to achieve the target recruitment rate; Studies show that manual process misses 27% of suitable candidates
- Connect healthcare and research systems to improve the capture and exchange of clinical trial data.Today… Over 40% of clinical trial data is entered manually into both healthcare and research systems; Transcription errors increase the workload for monitoring, querying, and responding to queries; Complex processes must be put in place to manage the ‘source’
The project will complete in 2015. During 2014 the project will be engaged in activities for externalisation of the platform and services.