Clinical Research and GCP Update

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Areas with most major findings!

Investigator Sites

• CRF Data / Source Data • Data integrity control • Protocol compliance • Medical oversight by the PI • Subject confidentiality • Research Ethics Committee • Record keeping/Essential Documents • Informed consent

• IMP management/pharmacy • Clinical sample management • Pharmacovigilance

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7 CRITICAL sponsor findings

1. Pharmacovigilance - RSI 2. Record keeping & essential documents 3. Clinical Trial Authorisation 4. Protocol compliance 5. Data integrity control processes

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