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Introduction: Good Clinical Laboratory Practices (GCLP) play a vital role in early and accurate diagnosis, providing high-quality data, and timely sample processing. Adhering to a robust Quality Management System (QMS) that complies with GCLP standards is crucial for laboratory personnel in a clinical laboratory to deliver outstanding healthcare services and reliable, reproducible reports. Aim: To assess the Knowledge, Attitude, and Practice (KAP) of laboratory professionals towards quality in the laboratory through GCLP training. Materials and Methods: This pre-test, post-test quasi-experimental study was conducted in the Department of Biochemistry at ESIC Medical College and Hospital, Faridabad, Haryana, India, from February 2022 to June 2022. The study included 58 participants, consisting of 22 doctors and the remaining laboratory assistants. GCLP online training program was conducted every Friday in March 2022 for four weeks. An online questionnaire containing 34 questions was administered to all the participants before and after the training. Data were collected and analysed using a paired t-test. Results: A total of 58 responses were received from the participants via Google form before and after the training. The results indicate no significant difference in participants' responses to 12 closed-ended questions regarding QMS before and after training. A similar trend was observed for 22 questions on a Likert scale, where participants rated their agreement, neutrality, or disagreement. Conclusion: The study demonstrates that all technical staff fully complied with GCLP guidelines and accreditation requirements. Furthermore, the laboratory staff acknowledges the importance of Standard Operating Procedures (SOPs), document maintenance, record-keeping, and identifying nonconformities, all of which contribute to effective traceability of the testing process in the clinical laboratory. [ABSTRACT FROM AUTHOR]

As notified in the New Drugs and Clinical Trials Rules 2019, ethics committees (ECs), intending to review and oversee the conduct of Biomedical and Health Research (BHR) shall be required to register with the authority designated by the Central Government in the Ministry of Health and Family Welfare, Department of Health Research (DHR). The entire process of receiving and processing such applications is done online through the Naitik portal. Vide these rules, it has become mandatory for all institutions/entities whether publicly or privately conducting or intending to conduct BHR involving the human participants, to get their EC, registered with the DHR. A status report of the functioning of the National Ethics Registry and an analysis of ECs registered with the DHR are presented in this manuscript. A workflow of the processing involved in EC registration is given with sectorial segregation, and analysis of data on ECs across the country is made for the dissemination and information. This article elaborates on the registration requirements and process of the EC registry with the necessity of being registered with the DHR. 2100 login requests and more than 1560 applications for registration have been received; private hospitals and medical colleges have been the front-runner in getting their organization registered, and organizations in the commercial sector are faring better in terms of EC registration. Further dissemination and outreach efforts have to be made to draw the attention of various stakeholders regarding this requirement and thereby ensuring that all ECs in the country are registered with the DHR. [ABSTRACT FROM AUTHOR]

Aims and Objectives: The ongoing COVID-19 pandemic is having a profound impact on the current clinical trials. We wanted to document the extent of the disruption amongst Indian clinical trial sites. Materials and Methods: We conducted an online survey among oncologists in India with active trials to document their experience with challenges and novel solutions. Results: A total of 60 oncologists replied of which 40 had ongoing trials with open recruitment. Majority of them had stopped screening (55%) and recruitment (62.5%). Almost half of the sites did not have adequate infrastructure (47.5%). Almost all the sites had enrolled patients worried about the impact of COVID-19 on their health outcome (up to 87.5%). The majority of sites had problems with adherence to study schedule of events (87.5%) and administration of study medication (42.5%). A total of 55% of the sites had provided the option of virtual visits. Both investigators (75%) and sponsors/contract research organizations (67.5%) had reached out to each other to maintain study integrity. More than half the centers had difficulty related to adverse events and serious adverse events (documentation and reporting; up to 75%). Discussion: Regulatory authorities in several countries have announced guidelines on the conduct of clinical trials during the COVID-19 pandemic. Whether the disruption lasts for a short or long time, its impact on clinical trials is going to be irreparable. [ABSTRACT FROM AUTHOR]

Coronavirus disease 2019 (COVID-19) has been declared as a pandemic by the World Health Organization on March 11, 2020. It has affected most countries of the world, including India. Both the disease and the unavoidable national response to it have posed unique challenges to our health-care system. A particular vulnerable group of patients is those with opioid dependence maintained on opioid substitution therapy (OST). These patients are pharmacologically dependent on the OST medication (buprenorphine, buprenorphine-naloxone combination [BNX], and methadone) for their healthy functioning and recovery. COVID-19 outbreak, lock-down, and difficult access to medical care, all are likely to induce stress and withdrawal, which is a potential risk for relapse among individuals with opioid dependence, who are anyway more vulnerable due to social, housing, living, and medical conditions. In this context, it is essential to re-strategize the existing OST services to adapt to the challenging circumstances. In this communication, we share our experience and formulate interim standard operating procedures (SOPs) for running a hospital-based OST service utilizing take-home BNX. The challenges, principles to meet the challenges, and interim SOPs are shared as being currently practiced in our center. Individual institutes, agencies, hospitals, and clinics running OST service with BNX can adapt these SOPs according to their characteristics, needs, demand, and resources; so long as, the basic principles are adhered to. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic impacted ongoing clinical trials globally resulting in the suspension, cancellation or transition to entirely remote implementation of studies. In India, the first countrywide lockdown was imposed in phases starting from March 2020 to June 2020, followed by a continued restriction on in-person activities including study procedures, which halted the ESSENCE (Enabling translation of Science to Service to ENhance Depression CarE) trial activities such as recruitment, consenting, baseline assessment, digital training orientation, face to face training and end-line assessment evaluation. This situation made it imperative to amend procedures in order to mitigate the risk and address safety requirements for participants and the research team. This paper summarizes the need, development and implementation of the protocols focused on risk reduction and safety enhancement with an objective to resume and continue the research activities while ensuring the safety of study participants and research staff. These protocols are comprised of guidelines and recommendations based on existing literature tailored according to different components in each arm of the trial such as guidelines for supervisors, travellers, training/recruitment venue safety procedures, individual safety procedures; and procedures to implement the study activities. These protocols can be adapted by researchers in other settings to conduct research trials during pandemics such as COVID-19., (Copyright © 2021 Elsevier B.V. All rights reserved.)