Global: ClinRegs Update – Sierra Leone (26-Jan-2015)

ClinRegs is an online database of country-specific clinical research regulatory information designed to save time and effort in planning and implementing clinical research.  With the publication of Sponsorship, Informed Consent, Investigational Products, and Specimens topics, the ClinRegs Sierra Leone profile is now complete. To receive notification of content updates, sign up for email updates using […]

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USA: Use of a Single Institutional Review Board for Multi-Site Research (26-Jan-2015)

Release Date: December 3, 2014 Response Date: January 29, 2015 Issued by: National Institutes of Health (NIH)   The National Institutes of Health (NIH) is seeking public comments on a draft policy to promote the use of a single Institutional Review Board of record for domestic sites of multi-site studies funded by the NIH. Background The NIH is […]

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UK: HRA Protocol Template Released for Consultation in Use (26-Jan-2015)

[Acknowledgements: Prof David Hutchinson, Canary Ltd] In collaboration with a wide range of partners, the Health Research Authority (HRA) has published a template and guidance for protocols for clinical trials of investigational medicinal products (CTIMPs). This is the first in a suite of templates for health research. The templates will be particularly valuable to new researchers, […]

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USA: ClinRegs Website – Aggregating Clinical Research Regulations from Around the Globe (13-Nov-2014)

The NIAID ClinRegs website provides an online database of country-specific clinical research regulatory information designed to enable users to explore regulations within a country and compare requirements across countries. By providing well-documented, up-to-date regulatory information for multiple countries in a single place, ClinRegs is intended to serve as a central resource and time-saver for persons […]

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EMA: Revision 1 of EMA GVP Module VI (03-Nov-2014)

The long awaited revision of EMA GVP Module VI (Management and reporting of adverse reactions to medicinal products) has been released and became effective on 16-SEP-2014. Revisions include: Revisions in VI.A.2.1.1. (Causality), VI.A.2.4. (Seriousness), VI.B.1.2. (Solicited reports), VI.B.3. (Follow-up of reports), VI.B.6.3. (Reports of overdose, abuse, off-label use, misuse, medication error or occupational exposure), VI.C.1. […]

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EMA: Reflection Paper on the Use of Patient Reported Outcome (PRO) Measures in Oncology Studies (01-SEP-2014)

The importance of the patient’s point of view on their health status is fully acknowledged and such information may in principle be used in drawing regulatory conclusions regarding treatment effects. This reflection paper on the use of patient reported outcome (PRO) measures in patients with malignancies focuses on the value of these data from a […]

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Italy: New Platform for the “National Observatory on Clinical Trials of Medicines” (OsSC)(1-SEP-2014)

The National Monitoring Centre on Clinical Research with Medicines [Acknowledgements: Prof David Hutchinson. Principal Author & Editor of Advisor] [NOTE – The following does NOT apply to observational studies] The National Monitoring Centre on Clinical Research with Medicines (Osservatorio Nazionale sulla Sperimentazione Clinica con i Medicinali; OsSC) monitors ongoing clinical trials in Italy.  The Italian […]

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