What is Protocol , Informed consent form , Different phases of clinical trials , Phase 1 objective , who are involved in clinical trials ?

Question

Accepted Answer

Protocol is a document that describe how will be conducted in clinical trials. Study design , methodology, statistical consideration in a clinical trials .

Informed consent form is a all information about the trial related information documents ex:- sign, dated, written

Phase-1:- primary aim is safety secondary aim is Tolerability

Clinical trials involved in healthy volunteers, sponser, investigator

Accepted Answer

1.Protocol is nothing but said to be as the fallowup procedure for work

2.Informed consent form is an agreement form between the participants and experimenters for well understanding.

clinical trails are actually 4 phases for different purposes: They are
phase 1 - deterimining safe dosage
phase 2- action of time or efficacy
phase3-identifying side effect
phase 4- pms (post marketing survilance )
after the drug introduced in to market to monitor the SAE reports
all the participants involved in the clinical trails like: participant
priniciple investigator
clinical reseach associate and cooridnators

What is Protocol , Informed consent form , Different phases of clinical trials , Phase 1 objective , who are involved in clinical trials ?

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