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Around the city

• Six years as a CRC. What does the first year as a CRA actually feel like?

  Changing functions · 0 answers

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• What do hiring managers want to see from an internationally trained physician applying for a CRA or CRC role?

  Internationally trained physicians · 0 answers

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• New to Canada, trained as a physician. Where does clinical research start for me?

  New to the country · 0 answers

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• Moving to Raleigh for a CRC role. How do I find the research people outside work?

  New in town · 0 answers

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• A coordinator just resigned mid-study. What are the first three things you do?

  Site operations · 1 answer

  Get the source and the drug log under someone's name today. Update the delegation log. Call the CRA before they hear it from someone else and agree a handover v

• When must a trial be registered and results posted on ClinicalTrials.gov?

  Trial conduct and operations · 1 answer

  ClinicalTrials.gov publishes the registration and results reporting requirements under US law on its policy page.

  Official source
• How do you prepare a site for an inspection without panic?

  Trial conduct and operations · 1 answer

  Start the week you hear. Make a list of what an inspector asks for first: delegation log, training, consent versions, drug accountability, the TMF index. Fix wh

• Where does EMA explain GCP inspections and compliance?

  Regulations and guidance · 1 answer

  EMA's Good clinical practice page covers GCP compliance, inspections and related guidance for medicines in the EU.

  Official source
• What do you do in a city on a Tuesday night when the visit ends at five?

  Travel · 1 answer

  Walk. One hour, no destination, phone in the pocket. Then dinner somewhere with people in it. The best advice I got as a new CRA was to treat every city as a pl

• Where is the UK's own GCP guidance for a UK site?

  Regulations and guidance · 1 answer

  The UK guidance Good clinical practice for clinical trials is published by MHRA on GOV.UK.

  Official source
• Where do EU trial applications go now, and what is CTIS?

  Regulations and guidance · 1 answer

  Applications under the EU Clinical Trials Regulation go through the Clinical Trials Information System (CTIS). EMA's page explains the regulation and links to C

  Official source
• What is the difference between a protocol deviation and a violation at your site?

  Regulations and guidance · 1 answer

  Most sponsors use 'deviation' for anything that departed from the protocol and 'important deviation' or 'violation' for the ones that affect safety or data inte

From the Library

• When must a trial be registered and results posted on ClinicalTrials.gov?

  ClinicalTrials.gov publishes registration and results reporting requirements under US law on its policy page. The source points to that page but does not descri

• Where does EMA explain GCP inspections and compliance?

  EMA's Good clinical practice page covers GCP compliance, inspections and related guidance for medicines in the EU.

• Where is the UK's own GCP guidance for a UK site?

  The UK's guidance titled "Good clinical practice for clinical trials" is published by MHRA on GOV.UK.

• Where do EU trial applications go now, and what is CTIS?

  Applications under the EU Clinical Trials Regulation go through the Clinical Trials Information System (CTIS). EMA's page explains the regulation and links to C

• Where does FDA say what counts as real-world evidence for a drug?

  The FDA guidance site lists Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological

• Where is the FDA guidance on home visits and remote trial activities?

  FDA's guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, covers trials where some or all activities take place away from tradi