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[Music] welcome to clinical gap we are gonna have a brief introduction to case report form and its design case report form the case report form is a tool used to collect all data from each participating subject or patient in a clinical trial the sponsor usually develops or outsources CRF development to collect the specific data they need to test their hypotheses and find answers to their research questions lets look at the definition of CRF as per IC h t CP CR f is defined as a printed optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject a working definition CRF is a tool designed by Sponsor to capture the transcription of protocol specific data from source document to CRF types of CRF designing a CRF is a crucial process in clinical trial and requires enormous planning and attention this will help in assessing the safety and efficacy of the medicine new product accurately broadly there are two