Advisor 469

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

STOP PRESS – global news

Filing email communications in the TMF New guidance is available on handling emails generated during a clinical study. The guidance was published by the Trial Master File (TMF) Reference Model, which is managed by the Drug Information Association Document and Records Management Community. The TMF Reference Model aims to address issues relating to the TMF as described in the International Council for Harmonisation E6 GCP Guidelines. The 21-page guidance document (published on 31 July 2020) provides new recommendations on managing email communications throughout a clinical study. The topics covered include • best practices • responsibility for filing emails • handling email attachments and threads • periodic review • email archiving and preservation The FDA has issued draft guidance to help sponsors design and analyse studies evaluating the impact of impaired renal function on the pharmacokinetics (PK) of investigational drugs. The new draft provides updated recommendations on the following: • when a dedicated PK study in participants with impaired renal function is recommended • the design and conduct of PK studies in those with renal impairment • characterising a drug’s PK in patients undergoing intermittent or continuous dialysis • the analysis and reporting of data from studies that characterise the impact of renal impairment and how these data inform dosing • using PK data from Phase 2 and 3 studies to inform dosing recommendations for patients with renal impairment. The 3-month comments period ends on 3 December 2020. Source: Follow us on Twitter @gcpadvisor FDA offers guidance on pharmacokinetic studies in renal impairment

NIH establishes research network on emerging infectious diseases The US National Institute of Allergy and Infectious Diseases (NIAID) has created the Centers for Research in Emerging Infectious Diseases (CREID), a global network to investigate how and where viruses and other pathogens emerge from wildlife and cause diseases in people. “The impact of the COVID-19 pandemic serves as a potent reminder of the devastation that can be wrought when a new virus infects humans for the first time,” said NIAID Director Anthony S. Fauci. “The CREID network will enable early warnings of emerging diseases wherever they occur, which will be critical to rapid responses.” Each centre in the network will collaborate with peer institutions in the USA and 28 other countries, on research projects including • identifying previously unknown causes of febrile illnesses in humans • identifying the animal sources of viral or other disease- causing pathogens • determining genetic or other changes that enable these pathogens to infect humans. Each centre will also have a geographical focus, and each will be poised to study any newly emerging “pathogen X”. Source: Following the gradual relaxation of measures to combat the spread of coronavirus in Switzerland, on 1 September 2020 the Swiss regulatory agency Swissmedic announced that it has decided to resume on-site regulatory inspections, subject to compliance with protective measures and assurances that the inspection process is safe for all involved. Prior to an inspection, companies must complete a questionnaire to confirm that the necessary protective measures are in place. The agency will only undertake an inspection if the inspected company can organise the necessary safeguards (meeting rooms with sufficient space, a restricted number of participants, electronic resources, etc.) and comply with social distancing and the use of face masks, as appropriate. Source: On-site inspections resume in Switzerland

• regulatory expectations and citations. Source:

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Issue 469, 2020

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