Record Retention Flashcards by Judy Phan

{ "@context": "https://schema.org", "@type": "Organization", "name": "Brainscape", "url": "https://www.brainscape.com/", "logo": "https://www.brainscape.com/pks/images/cms/public-views/shared/Brainscape-logo-c4e172b280b4616f7fda.svg", "sameAs": [ "https://www.facebook.com/Brainscape", "https://x.com/brainscape", "https://www.linkedin.com/company/brainscape", "https://www.instagram.com/brainscape/", "https://www.tiktok.com/@brainscapeu", "https://www.pinterest.com/brainscape/", "https://www.youtube.com/@BrainscapeNY" ], "contactPoint": { "@type": "ContactPoint", "telephone": "(929) 334-4005", "contactType": "customer service", "availableLanguage": ["English"] }, "founder": { "@type": "Person", "name": "Andrew Cohen" }, "description": "Brainscape’s spaced repetition system is proven to DOUBLE learning results! Find, make, and study flashcards online or in our mobile app. Serious learners only.", "address": { "@type": "PostalAddress", "streetAddress": "159 W 25th St, Ste 517", "addressLocality": "New York", "addressRegion": "NY", "postalCode": "10001", "addressCountry": "USA" } }

Q

The IRB/IEC should retain all relevant records…

A

For at least 3 years after completion of the trial

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Q

Investigator essential documents should be retained…

A

At least 2 years after last approval of marketing application in ICH region
Until there are no pending marketing applications
At least 2 years have elapsed since formal discontinuation of product

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Q

IRB must renew registration

A

Every 3 years

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Q

Health Canada retains records for…

A

25 years

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Q

A sponsor shall retain the records and reports for…

A

2 years after a marketing application is approved for the drug OR
2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.

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