Shruti chola 1 26 March 2012

CLINICAL TRIAL CHECKLIST

ASSIGNMENT III

SHRUTI CHOLA 022115322

Shruti chola 2 26 March 2012

OBJECTIVE:
To prepare a Clinical Trail Checklist for Evaluation of Anti depressant activity of Bupropion.

S.No.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Requirements
Finalized Clinical trial protocol Review and approval of the protocol by IRB. Check for availability of resources ( people, money , time) Clinical Trial Design Determination Of End Points Inclusion and Exclusion Criteria Of patients Determination of subject withdrawal criteria or procedures List of participating sites Credentials of site IRB approval for all participating sites in case of Multicenter studies. Recruitment of Investigators Training of Investigators at the sites Recruitment of subjects Informed consent of the subjects Agreement of supply of drug by the provider, intended to study. Monitor safety of subjects

Y/N
Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y

Shruti chola 3 26 March 2012

Y 17 18 19 20 21 22 23 24 25 Measures to protect participants Ensure that the study has enough power Specification of efficacy parameters of the investigational drug Specification Of Safety parameters of the investigational drug Criteria for termination of trial Establishment of Data and Safety Monitoring Board Methods for management of clinical trial data Measures for proper data handling techniques Preparation of Case Report Forms and Electronic data capturing Y Y Y Y Y Y Y Y Y