AurouSpeak - The quarterly newsletter from Aurous HealthCare CRO Vol 01 Ed 02

AurouSpeak AURO Quiz… Clinical Research AUDIO-VIDEO RECORDING OF INFORMED 1. Which is the document mandatory to enroll a subject CONSENT PROCESS MANDATORY - DCGI… into a study? A. Protocol B. Informed Consent Document C. Voters ID D. All of the above 2. Who finances a Clinical Study? A. Project Manager B. Sponsor C. CRA D. Vendors 3. Identify this person who is generally credited as the father of clinical research. Clue: Oranges. Next Edition: How well do you understand Osteoporosis?? Answers on Page 4 With the official gazette notification in June 2013, CDSCO has mandated the audio-video recording of the informed consent process in all global clinical studies. This audio video recording was also to cover the procedure of providing information to the subject and his understanding on the subject. It is also mandated that the investigator provide information about the study verbally as well as using a patient information sheet, in a language that is non-technical and understandable by the study subject. The subject’s consent must be obtained in writing using an “Informed Consent Form” apart from the audio video recording of the entire procedure. Though the DCGI has made it imperative that all sponsors/CRO and other stakeholders involved in the conduct of the clinical trials, adhere to this effect immediately, there are many questions left unanswered by the office of CDSCO.      Storage format of the AV recording. Confidentiality issues about storage of such an open evidence. Monitoring of the same by CRA. Duration of storage and policy for destruction. If the recording is to be performed for EVERY subject at a trial site. Until such questions are answered , it does leave room to a lot of ambiguity but this is a string initiative from CDSCO to ensure the safety of the subject. EXERCISE IS JUST AS EFFECTIVE AS DRUGS : RESULTS OF CLINICAL STUDY… Scientists claim that exercise may be just as effective as drugs for treating common conditions, such as coronary heart disease and stroke. It has long been established that regular exercise is beneficial for health in general, but researchers now think exercise is "potentially as effective" as drug intervention, and they suggest it "should be considered as a viable alternative to, or alongside, drug therapy." Physical activity has well-documented health benefits, yet in England, roughly one-third of adults meet the recommended levels of physical activity. Physical activity has well documented health benefits. Population level cohort studies have shown that people who exercise enjoy a higher quality of life and improved health status compared with those with sedentary behaviours, with subsequent reductions in their risk of adverse outcomes such as admissions to hospital. Randomised controlled trials have shown similarly favourable findings in arthritis, cancer, diabetes, heart disease, and respiratory illnesses, among other chronic conditions. Large scale observational studies have also established a clear association between exercise and all cause mortality. Characteristics of exercise interventions The characteristics of the exercise interventions varied across treatment areas. Differences included the mode of physical activity and its frequency, intensity, and duration. Exercise based

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