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This one is a good report. But let me bring about a glaring fact while the PI recruits subjects especially for paediatric vaccine trials.
"Most busy and renowned paediatricians or doctors [PIs] delegate the duty of recruitment and physical examination to their junior/senior residents; also the administration of the vaccine or Inv product.
Also the PI does not even bother to observe the subject for immideate AEs.
Only after the CRFs are ready and site close out is due ;he/she with lot of coaxing from the sponsor puts his final signature.
We are in dire need of trained/clinical research oriented pool of PIs.
I hope you agree with me??
Badrinarayan