ABSTRACT
The monitoring of clinical trials is an integral function of the institutional ethics committee (IEC)to ensure the ethical conduct of research. The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, of the Indian Council of Medical Research, underline a strong need for active monitoring of clinical trials. A previous study by the authors, of research studies initiated between 2008 and 2010, had found many lapses after site monitoring. In the present study, 12 clinical studies—both sponsored and investigator initiated—were monitored by members of the King Edward Memorial Hospital (Mumbai) IEC between 2011 and 2017. The most common violations seen were related to informed consent (8/12 sites). The other violation themes were lack of investigator understanding of protocol (6/12), deviation from the investigational plan (5/12), non-reporting of the study’s progress to the IEC (4/12), and patient recruitment prior to IEC approval (2/12). The IEC took various corrective actions, such as ordering retaking of consent and good clinical practice (GCP) re-training and requiring interim reports, explanations for deviations, upgradation of facilities, and payment of pending compensation. The IEC even froze review of protocols from a frequently defaulting Principal Investigator’s (PI) site and put study recruitment on hold for the same PI. This study demonstrates that active site monitoring by IECs is a must for ensuring the ethical conduct of studies
ABSTRACT
Background: Rotational training programme for the postgraduate students of pharmacology should be planned with the aim of making them competent as pharmacologist. Thus in the present study we decided to develop a rotational duty programme and evaluate perception and attitude of postgraduate student towards it. Methodology: We developed a rotational duty programme at our department which was structured by defining objectives to be achieved, content to be learnt, weekly targets to be accomplished and assessment to provide feedback to the students. The perception and attitude were recorded using a questionnaire in which their adequacy of duration of posting; adequacy, relevance and implementation of weekly time table; adequacy and relevance of the training imparted in the posting; quality and pattern of assessment and their perceived benefit from the rotational training program were assessed. Results: Postgraduate students found the programme adequate and relevant in terms of duration, implementation of weekly targets, training imparted and quality of assessment. Students also perceived the programme as beneficial. Suggestions were given by the students in the areas they considered modification is required. Conclusion: Suggestion given by the students along with discussion by faculty members were incorporated in improving the standard and strengthening the programme. There is a need for development of such programmes to improve the standards in postgraduate teaching in pharmacology. These programmes also need to undergo relevant amendments in order to improvise them.
ABSTRACT
Background: The postgraduate education depends on self learning. Knowledge acquisition among postgraduate students is through seminars which form essential part of their training programme. Methodology : This study assesses the role of seminar as a teaching-learning tool amongst students & teachers by recording their perception through a questionnaire based survey. Results : The scores for most of the items in an 18 point questionnaire were above 3 indicating that learning from seminar is satisfactory. There were two items where there was significant difference among students & teachers perception. Conclusion : We found that both the postgraduate students and the postgraduate teachers feel that the technique is useful amidst lots of suggestion to improve the quality. Thus the postgraduate seminar method is a teaching-learning method that is effective and well-accepted among the postgraduate students and postgraduate teachers alike..