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Good Clinical Practices
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Good Clinical Practices
IEC should oversee all stem cell research in the institute
,
December 04, 2024
GCP protocol doesn’t permit enrolment of illiterate participants
,
November 06, 2024
GCP of contract mentions investigator, institution separately
,
October 03, 2024
ICMR 2017 guidance considers diagnostic agents, devices as interventions
,
September 06, 2024
FDA GCP inspection observations are captured in EIR
,
July 31, 2024
If a non-serious AE becomes serious, it should be recorded as AE
,
July 03, 2024
GCP guidelines say rights to withdraw from a clinical trial
,
June 05, 2024
Rules make AV consent mandatory for phase III clinical trial
,
May 01, 2024
There are issues to be considered while implementing participant recruitment website as a recruitment tool
,
April 03, 2024
ICH GCP 8.3.14 mandates investigator should keep copy of CRF
,
March 06, 2024
Sponsor is responsible for validation of clinical trial processes
,
January 31, 2024
US FDA guidance says volunteers for clinical evaluation should be free from abnormalities
,
January 03, 2024
Digital Personal Data Protection Act impacts many trial conduct processes
,
December 06, 2023
Clinical trials for medical devices are different from clinical trials of drugs
,
November 01, 2023
There is no regulatory ban against an investigator’s family member participating in a clinical trial
,
October 04, 2023
It is essential for investigator to obtain HMSC clearance
,
September 06, 2023
EC should consider unapproved proposals as new proposals and review thoroughly
,
August 02, 2023
EC should review content of evaluation instruments
,
July 04, 2023
GCP norms recommend sponsor should notify regulatory authority
,
May 31, 2023
EC review should focus on all potential ethical issues
,
May 04, 2023
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