Good Clinical Practice (GCP), lecture # 5-Safety Reporting

Dr.Naeem Noordin, SIARA Limited UK Good Clinical Practice (GCP)
What is Good Clinical Practice?
Good Clinical Practice (GCP) is an international ethical and scientific standard for conducting biomedical and behavioral research involving human participants. The objective of this guideline is to provide a unified standard to facilitate the mutual acceptance of data from clinical trials by Regulatory Authorities in different countries
Why is GCP training necessary?
This training is important for all staff involved in Clinical Research and ensures an understanding of the principles adopted in the research. GCP is widely accepted and expected in all research involving human participants. GCP is not specific to a protocol, but rather is general and applicable to all protocols. Anyone directly involved in the design, conduct, oversight, or management of research involving human participants, need to hold a GCP Certificate

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You're a legend for this, thanks!

[@mrscham7871]

Very insightful! Thanks.

[@thomvudhyhp92]

Thank you for your great presentation. May I ask you a question? If the patient detects diabete when they took part in the study in few days. It would be consider an AE? Thank you much.

[@susanromano5705]

If a patient dies in less than 30 days from on study and not related to study interventions, are we obligated to notify our IRB

[@fafywalid]

Please I can not find lecture 4 from good clinical practice

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