1. ICF review,Review of volunteer screening documents,Review of Check-in documents,Review of TMF (Trial Maser file),Monitoring of IMP dispensing,Monitoring of dosing activity and review of dosing documents,Review of labeling information and documents ( Test and reference drugs ,Vacutainers, Cryo vials),Monitoring of PK sample collection, processing and storage,Monitoring of Vital signs activity and review of vital signs documents. Investigational product accountability documents and All study related documents. 2. Clinical Trial (BA/BE) studies Auditing