True or False with explanation: True or False? : Computerized Systems used in Cl

Question

True or False with explanation:

True or False? :  Computerized Systems used in Clinical Investigations must follow the same FDA regulatory requirements that cover software in medical devices.

True or False? :  ICH and ISO have established Global Quality Standards, which can be applied to Outsourcing activities.

True or False? :  The provisions for “transfer of responsibilities” are the same for both drug and device clinical studies regulated by FDA.

True or False? :  All 21 CFR Part 312 and 812 regulations apply equally to both paper and electronic records.

True or False? :  The most common BIMO deficiencies cited at Clinical Investigator sites include: Inadequate Monitoring, Failure to secure investigator compliance, and Failure to obtain signed Investigator Agreement.    

True or False? :  FDA does not have legal authority or jurisdiction outside of the United States and occupied territories.    

Explanation / Answer

1. True : Because, compliance to the FDA guidelines ensures that the safety and confidentiality of data is maintained at all stages of the process.

2. True : The company itself is responsible for the monitoring and control of outsourced activities and quality of the service, so the systems followed at its place can be extended to the outsourced activities also.

3.False : In case of drug regulation, the transfer of responsibilities is defined whereas in case od device regulations, the provision don't allow transfer of responsibilites to Contract Research Organisations.

4. True : All 21 CFR Part 312 and 812 regulations apply to both electronic and paper records.

5. True : The most common deficiencies found are related to investigator accountability records, consents and compliance to the regulations.

6. True : FDA does not have jurisdiction beyond the US and its territories.

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