In this study, students preferred an active learning environment, though to pass examinations, they preferred the tutorial mode of teaching. Further efforts are required to explore the effects on learning of introducing similar modules for other topics.

Protocol deviations (PDs) may jeopardize safety, rights, and welfare of subjects and data integrity. There is scarce literature and no guidelines for Institutional Ethics Committees (IECs) to process PD reports. The PD reports submitted to IECs from Jan 2011 to August 2014 were analyzed retrospectively. Types of studies reporting PDs, category and type of PDs, PD rate per participant, time of reporting PD since its occurrence and corrective actions stated by principal investigator (PI) for major deviations were noted. Out of 447 PDs from 73/1387 total studies received during study period, 402 were from 126 pharma studies. Investigator initiated studies and dissertations reported negligible PDs. Median number of PDs was 4 per protocol. Out of 447 PDs, 304 were related to study procedure, 87, 47 and 9 were from safety, informed consent document (ICD) and eligibility category respectively. The most common reason for PDs was incomplete ICD (22/47). Maximum study procedure related PDs were due to patient visiting outside window period (126/304). Thirty five of 87 PDs were due to missed safety assessment. The overall PD reporting rate per participant was 0.08. In 90% of reports, date of occurrence of PD was not specified. The median delay for reporting PDs after occurrence was 94 days. PDs classified as Major were 73% (323/447). The most common corrective actions stated by PI were participant counseling (85/323) and caution in future (70/323). The study findings emphasize the need for GCP training at regular interval of study team members. IEC have to be vigilant and visit sites frequently, take initiative and formulate guidelines regarding PD reporting.

Objectives:Underreporting and poor quality of adverse drug reaction (ADR) reports pose a challenge for the Pharmacovigilance Program of India. A module to impart knowledge and skills of ADR reporting to MBBS students was developed and evaluated.Materials and Methods:The module consisted of (a) e-mailing an ADR narrative and online filling of the “suspected ADR reporting form” (SARF) and (b) a week later, practical on ADR reporting was conducted followed by online filling of SARF postpractical at 1 and 6 months. SARF was an 18-item form with a total score of 36. The module was implemented in the year 2012–2013. Feedback from students and faculty was taken using 15-item prevalidated feedback questionnaires. The module was modified based on the feedback and implemented for the subsequent batch in the year 2013–2014. The evaluation consisted of recording the number of students responding and the scores achieved.Results:A total of 171 students in 2012–2013 batch and 179 in 2013–2014 batch participated. In the 2012–2013 batch, the number of students filling the SARF decreased from basal: 171; 1 month: 122; 6 months: 17. The average scores showed improvement from basal 16.2 (45%) to 26.4 (73%) at 1 month and to 27.3 (76%) at 6 months. For the 2013–2014 batch, the number (n = 179) remained constant throughout and the average score progressively increased from basal 10.5 (30%) to 27.8 (77%) at 1 month and 30.3 (84%) at 6 months.Conclusion:This module improved the accuracy of filling SARF by students and this subsequently will led to better ADR reporting. Hence, this module can be used to inculcate better ADR reporting practices in budding physicians.

Introduction: Pharmacology subject though crucial for physicians, is perceived as dry, volatile by medical students. Active teaching-learning techniques in pharmacology are required to increase the interaction and interest among the students. Objective: To evaluate the perception of students about two innovative teaching techniques role play method (RPM) and case based learning (CBL) in pharmacology. Method: Institutional Ethics Committee permission was obtained. II MBBS students gave written informed consent to participate in this study. The topic "rational pharmacotherapy" was taught to 6 small batches of approximately 18-20 students each. While CBL (n=84) was used for three batches, RPM (n=80) was applied for remaining three batches. After the session, a pre-validated perception questionnaire, containing 15 questions using Likert scale and open ended questions, was administered to the students. Result: Majority of students (CBL: 88.10% and RPM: 93.75%) appreciated these methods and felt it facilitated their understanding. These methods enhanced their intellectual curiosity (CBL: 57.14% and RPM: 73.75%), and were interactive (CBL: 71.43% and RPM: 90.00%). Learning atmosphere was perceived as comfortable (CBL: 82.14% and RPM: 77.50%). Students were satisfied with the respective techniques (CBL: 63.10% and RPM: 55.00%) and agreed that knowledge and skill acquired by these techniques will help them in clinical practice (CBL: 78.57% and RPM: 91.25%). Conclusion: Students' opinions for both the methods were favourable, though more inclination was towards RPM as it is more helpful for clinical decision making process. Trained facilitators can overcome the shortcomings perceived in CBL as well as in RPM.

The Government of India came out with a slew of notifications to streamline clinical research in the beginning of 2013 in response to the Supreme Court's orders and a Parliamentary Standing Committee's report. The notifications greatly influenced the structure, review process, outcomes and administration of ethics committees across India. In this study, we attempted to objectively evaluate the impact of these notifications on our institutional ethics committee's (IEC) structure, review process, outcomes and administration. The results revealed that though the number of regulatory studies reviewed by our IEC remained the same, the number of studies actually approved decreased with an increase in the turnover time. The number of serious adverse events (SAEs) reported also fell, although the number of meetings held to discuss these SAEs increased significantly. The administrative workload rose with increased documentation. Though the annual income of the IEC fell marginally, the expenses shot up. We believe that the notifications definitely had an impact on the structure, review process, outcomes and administration of our IEC, although it remains to be seen whether they had a real impact on the research participants' safety and well-being.