Easily Delete Date from the Clinical Trial Agreement

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How to Delete Date from the Clinical Trial Agreement

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hey everyone its dance fair from the clinical trials guru back with yet another video every day I try to do more than one a day but today Im doing this one its a pretty special video somewhat important as I tell you guys all the time you especially you research clinics but this doesnt just apply for to research clinics it applies to everybody in this industry whether you work for a CRO whether youre a p.i wanting to network with other p is whether your site director of a research clinic even sponsors its so important in this industry to network with your colleagues even if its from competing companies even the Big Pharma is doing this now youre seeing a lot of collaboration going on between Big Pharma so theres no reason as research sites should not be able to do this so Im part of of several groups on LinkedIn there are some Google Plus groups theres my special cyber dusters for those of you who dont know cyber dust is an app you can add me dance vera im planning to start

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How long is clinical trial data stored?

HIPAA Requirements: Any research that involved collecting identifiable health information is subject to HIPAA requirements. As a result records must be retained for a minimum of 6 years after each subject signed an authorization.

What is the study completion date?

Study Completion Date: the date that the last data point for all remaining outcome measures was collected from the last enrolled participant.

How long do clinical trial documents need to be kept?

Research Records must be maintained a minimum of three years after the research is completed and the study closed with the IRB.

What is study completion date in clinical trials?

The Primary Completion Date? o Definition: This is defined as the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome whether the clinical trial concluded ing to the prespecified protocol or was terminated.

How long does FDA require storage of trial records?

An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication

How long does NIH require records to be kept?

Recipients generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FFR is submitted.

How long should the sponsor and investigator retain essential documents?

Sponsor and Investigator must retain records for 2 years after marketing or 2 years after investigational use is discontinued and FDA notified.

How long do you have to keep essential documents for a clinical trial?

The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3-years after completion of the trial and make them available upon request from the regulatory

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