The Role of Site Initiation Visits and Essential Documents in Maintaining Integrity and Compliance in Clinical Trials

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Page: 301-305

Kuldeep Kumar¹, Anshuman Nigam², Saanvi Dullu³, Harman Tej Singh⁴, Adarsh Keshari⁵, and Minakshi⁶ (Fortis CSR Foundation (Clinical Research Division) and Fortis Healthcare Limited¹, Fortis Healthcare Limited, Bachelor of Engineering Student at Birla Institute of Technology and Science Pilani, Goa Campus², Fortis Healthcare Limited, Bachelor of Pharmacy Students at Birla Institute of Technology and Science Pilani, Hyderabad Campus³,⁴, Fortis Healthcare Limited, Doctor of Pharmacy student at Teerthanker Mahaveer College of Pharmacy, Teerthanker Mahaveer University, Moradabad, Uttar Pradesh⁵, and Assistant Professor, GD Goenka University, Gurugram, Sohna Rural, Haryana⁶)

Clinical trials are very important for determining the safety and efficacy of medical trials, which is further critical to the progress of the various healthcare businesses. Conducting such studies requires substantial preparation and adherence to the various ethical norms; such norms which are especially crucial when dealing with medical emergencies like the COVID-19 outbreak. This paper discusses the Site Initiation Visit (SIV) and the development of Essential Document Files (EDF) for clinical research. Site initiation visit specifies fundamental tasks to ensure team preparedness, logistical planning, and regulatory compliance. Team training, investigational product (IP) storage, and post-SIV follow-up procedures are all valuable considerations. On the other hand, throughout the trial’s lifecycle, the document files play a very vital role in ensuring a complete documentation process thereby promoting transparency and adherence to Good Clinical Practice (GCP) guidelines. The paper highlights the importance of established protocols and regulatory compliance, in safeguarding safety by outlining these procedures.