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April 30, 2014

EU News on Clinical Trials Regulations
Council adopts new rules on clinical trials

The Council approved on 14 April 2014 a draft regulation aimed at facilitating and speeding up the authorization procedure of clinical trials, following the first-reading agreement reached with the European Parliament in December (PE-CONS 2/14 + 8245/14 ADD 1).
This means that the regulation is now adopted. It will enter into force 20 days following its publication in the Official Journal of the European Union and apply six months after a EU portal for the submission of data on clinical trials and a EU database identifying each clinical trial have become fully functional (but not earlier than two years after the regulation's publication).

Pdf release    More details online

MHRA, TMF (Trial Master File) and the Definition of Inspection Findings
Updated definition of a critical GCP inspection finding

The GCP Inspectorate has updated their definition of critical to include, ‘where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations.’
This following numerous issues with inspector access to TMFs and incomplete TMFs. The TMF provides the basis for inspection by the competent authority (2005/28/EC). The UK Clinical Trial Regulations (2004/1031, Regulation 31A) require that the sponsor must keep a TMF and it must be readily available and shall at all times contain the essential documents relating to the trial. The essential documents relating to a clinical trial are all the documents that enable both the conduct of the clinical trial and the quality of the data produced to be evaluated and show whether the trial is, or has been, conducted in accordance with the applicable requirements of EU Directives, UK Clinical Trial Regulations and relevant guidance.
Over the last year, 35% of commercial sponsor inspections have resulted in extra days having to be added to complete inspections where there have been difficulties ensuring the TMF is complete and readily available. This is particularly problematic with electronic TMFs. Therefore inspectors are not getting access to documents needed to conduct an inspection, or because of the nature of the TMF are only able to complete a review of the nature and completeness of the TMF and not a review of the compliance of the trial itself. Essentially this means that inspectors are not able to discharge their duties in terms of inspection and protecting public health, and therefore merits a critical finding.

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Public Disclosure of Results of Clinical Trials conducted in the EEA (European Economic Area)
The European Medicines Agency (EMA) announces final consultations on its clinical trial data policy will begin at the start of May

In keeping with the adoption of the Clinical Trials Regulation EMA refines its transparency policy and is initiating a public consultation with the pharmaceutical industry, academia and patients’ representatives. EMA stated that clinical study reports can be redacted to remove “those parts of clinical trial data that exceptionally contain commercially confidential information.“ From 2016, or at the latest when EMA has completed the development of the required software, sponsors will be required to publish detailed reports of all clinical trials conducted within the EEA. The sponsor will need to post detailed data on a publicly accessible database, cf. Article 78 of the Regulation. Data will include details of the sponsor, end-points investigated, details about the patient population and their recruitment as well as about adverse events.

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Clinical Data Sharing Could Increase Research Costs, Industry Fears
A new hurdle for academic researchers?

This week's Pink Sheet posted an article Clinical Data Sharing Could Increase Research Costs, Industry Fears noting that "NIH-funded investigators may direct money away from research to prepare their data for public release; some wonder whether grants should include the cost.
Please consider that a subscription to the Journal is needed to access the full article.

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4th Global QA Conference / 30th SQA Annual Meeting in Las Vegas
The DGGF Conference slot presented an European View of Risk based Monitoring

Dr. Gabriele Schwarz from BfARM talked about “Risk-based quality management of clinical trials – What is special about the concept?” She presented the major conclusions from the Inspectors Working party Reflection Paper and also stressed the importance of a properly designed protocol as an enabler of a Risk based Monitoring approach. She also emphasized that decisions driving “adaptive monitoring” must be fact based and thresholds should never be used to justify “after the fact’ inadequate compliance with protocol or GCP.
Dr. Beat Widler from Widler & Schiemann Ltd. in his talk, “Risk based Monitoring, an European View” seconded Dr. Schwarz’s comments and stressed the importance of “validating” risk indicators and their thresholds with objective data so that auditors and inspectors can verify that “what was considered a low risk by the sponsor” is indeed a low or acceptable risk. Traditional monitoring and auditing techniques such as on-site data reviews can contribute to this verification. In this context he also challenged the distinction introduced by TransCelerate between source data verification (SDV) and source data review (SDR) as this introduces additional complexity and misses the point that credibility needs to be bestowed to any risk assessment or decision matrix driving study oversight activities. On site verification is part of this “validation effort”.
Download of presentations requires a password; if interested in my side deck, please, contact me at

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Short General News from FDA
CBER is moving

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Proposed health IT strategy aims to promote innovation, protect patients, and avoid regulatory duplication

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Short Medical Device Related News from FDA
Draft Guidance for Industry and Food and Drug Administration Staff

Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval

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Draft Guidance for Industry and Food and Drug Administration Staff

Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions

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FDA proposes new expedited access program for medical devices that address unmet medical needs

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