Request for randomization schedule generation from biostatistician according to protocol in coordination with PI.
Dispensing of different dosage form of IMPs.
Maitainance of IMPs accountability.
To perform retention, send back or destruction of IMPs.
Review of IMPs documents to ensure accuracy, completeness, and compliance with protocol, SOP and regulatory guidelines.
Manage the Pharmacy according to the SOP’s. and GMP.
Request and receipt of study specific documents from QA.
Ensure the appropriate periodic maintenance and calibration of equipments like Humidity Chamber, Cold Chamber and Laminor Air Flow etc.
Compilation of study specific TMF (prior to study).
Readiness of the CPUs with the support of HK staff.
Place indents to procure material / supplies needed for the study.
Self-checking of protocol training completion.
Reporting of eligible volunteer’s/subjects for study admission.
Providing ICD presentations to volunteers in groups.
Perform admission, discharge, meal distribution, reporting, and monitoring of subjects during the clinical study conduct.
Supervision of activities of other study personnel (CRTs, RNs) during the conduct of clinical study.
Compilation and review of study data and ensuring the compliance with SOPs and protocol during the study conduct.
Compilation of study documents on timely.
Responsible for submission of study documents (ICDs, CRFs and TMFs) to QC, QA for review and subsequent closure of observations in consultation with Study PIC/ PI or designee.
Assist the PIC for the archiving of study documents.
Identification of the SOP / protocol deviations and bring it to the notice of project in-charge for recording.
Compliance and data integrity during study execution with SOPs and regulatory requirements.
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