Year : 2022  |  Volume : 9  |  Issue : 1  |  Page : 31-35

Brief technical guide for registration of an observational study protocol

1 Department of Physiology, Santiniketan Medical College, Bolpur, West Bengal, India
2 Department of Physiology, Raiganj Government Medical College and Hospital, Raiganj, West Bengal, India
3 Department of Physiology, Hi-Tech Medical College and Hospital, Bhubaneswar, Odisha, India

Correspondence Address:
Himel Mondal
Department of Physiology, Santiniketan Medical College, Bolpur, West Bengal
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijves.ijves_87_21

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Background: Clinical trial registration is a must for the conduct of an interventional study. The registration should be in the repositories accepted by World Health Organization (WHO) and endorsed by the International Committee of Medical Journal Editors (ICMJE). These registries allow the registration of both interventional and observational studies. However, the majority of the observational studies are not registered. Aims: We aimed to find the current share of observational studies in various registries and to provide a brief technical guide on the process of registration of an observational study in the Clinical Trials Registry – India (CTRI) and in the open science framework (OSF). Methods: We searched the WHO and ICMJE websites for the list of accepted registries. The number of interventional and observational studies in those registries was collected. Then, we described the process of registration of an observational study in CTRI and OSF. Results: The highest number (83,866) of observational studies is present in ClinicalTrials.gov. However, according to percentage, the DRKS - German Clinical Trials Register has the highest percentage (31.57%) of observational studies. The CTRI has 25.33% and ClinicalTrials.gov has 21.91% observational studies. The registration of an observational study protocol is acceptable online and free of cost in the CTRI and OSF. Conclusion: It is not mandatory to register purely observational studies. However, the registration may bring transparency in scientific reporting and help to avoid publication bias towards positive results. The technical glimpse in this article would help the novice authors in registering their observational study protocol in an open repository.

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