keerthi mundhra

* Internship Experience (01/06/2011 to 30/11/2011): * As part of my internship I have performed the following task meeting the given timelines. * Protocol Writing: Developed the protocol as per the ICH GCP, 21 CFR and Indian GCP. * Budget Preparation: Prepared the budget for the Study as well as the Site. * CRF design: Designed the CRF capturing all the study events as per the protocol requirements. * Source Document and Subject Diary: Prepared the socurce document and also subject diary capturing the treatment and study assessments as per the protocol. * ICD: Prepared the informed consent form and the Patient Information Sheet as per Schedule Y and ICMR Ethical Guidelnes for Biomedical Research. * Logs, Forms and Reports: Prepared the study specific logs, forms and reports. * SIV, Monitoring, Close out visits: Performed mock initiation, monitoring and close out visits of the study. * Prepared and submitted EC dossier * Completed CRF’s and other study related documents using dummy subject data. * Compiled and maintained the TMF’s and ISF’s

1.Managed regulatory documents and clinical trials manuals; designed patient tracking charts using spreadsheets and formulated source documents and data collection charts 2.Has facilitated completion of clinical charts and case report forms also controlled quality of data retrieved from hospital records and reported research activities to team. 3.Managed budgets, expenses and funding 4. Have developed feasibilityquestionnaire for physicians