protocol writing (3)

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6. Selection and Withdrawal of Subjects

This is going to be discussed in the next segment of this workshop. Hence, only the salient features here.

v Subject inclusion criteria.

v Subject exclusion criteria.

v Subject withdrawal criteria (i.e. terminating investigational product treatment/trial treatment) and procedures specifying:

(a) When and how to withdraw subjects from the trial.

( The type and timing of the data to be collected for withdrawn subjects.

© Whether and how subjects are to be replaced.

(d) The follow-up for subjects withdrawn from trial treatment.

7. Treatment of Subjects

v The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s) for subjects for each trial treatment group/arm of the trial.

v Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial.

v Procedures for monitoring subject compliance.

8. Assessment of Efficacy and Safety (to be discussed in the subsequent segments of the workshop)

v Specification of efficacy and safety parameters.

v The methods and timing for assessing, recording, and analysing efficacy and safety parameters.

v Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses.

v The type and duration of the follow-up of subjects after adverse events.

dr. Smita

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