Answer :
The investigational product dispensing or administration information for the sponsor is recorded on the Case report form.
The investigator/institution is ultimately responsible for product accountability at the study site.
What is product accountability?
It is intended to instill the idea that performance evaluation of a product manager and product team should focus on how well the product performs over time in relation to the organization's goals rather than on delivery.
What is included in a case report form?
The inclusion criteria, exclusion criteria, demography, medical history, PE, AE, concomitant medication, and study outcome modules are the most often used standard CRF templates, however the modules that capture efficacy data are not unique. The design of these studies differs depending on the protocol requirements.
Is a case report form a source document?
Although it shouldn't be standard procedure for all data collected during a clinical trial, case report forms (CRFs) may be utilized as source documents if data will be originally recorded on the form and the intended purpose is prospectively mentioned in the protocol.
Learn more about source documents: https://brainly.com/question/207486
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