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Whats the definition of source data correct answer

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What's the definition of source data? Correct Answer:All information in original records andcertified copies of original records of clinical findings, observations, or other activities in aclinical trial necessary for the reconstruction and evaluation of the trial.
Examples of electronic systems utilized in clinal trials? Correct Answer:- electronic medicalrecords- electronic case report forms (eCRFs)
- electronic diariesA number of attributes are considered of universal importance to source data and the records that
Password protection allows monitors and auditors to confirm that subjects confidentiality wasmaintained as well as providing a methodology to confirm that only individuals with appropriateeducation, experience and training completed study related procedures as tasked on a what?
General regulatory expections for electronic systems include: Correct Answer:- Passwordcontrol- Audit trail- Appropriate access by qualified personnel (read vs write access)
Electronic systems are being used in collaboration by sponsors and sites to: Correct Answer:-
Capturing source data electronically and transmitting it to the electronic case report form should?
When allowing clinical research associates to review electronic medical records systems which

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Term
Fall
Professor
professor_unknown
Tags
Correct Answer, Clinical trial, investigator

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