Clinical Trials & Management detail syllabus for Biotechnology (Biotech), 2019-20 scheme is taken from AKTU official website and presented for AKTU students. The course code (RBT073), and for exam duration, Teaching Hr/Week, Practical Hr/Week, Total Marks, internal marks, theory marks, and credits do visit complete sem subjects post given below.
For all other biotech 7th sem syllabus for b.tech 2019-20 scheme aktu you can visit Biotech 7th Sem syllabus for B.Tech 2019-20 Scheme AKTU Subjects. For all other Departmental Elective-III subjects do refer to Departmental Elective-III. The detail syllabus for clinical trials & management is as follows.
Unit I
For the complete syllabus, results, class timetable and more kindly download iStudy. It’s a lightweight, easy to use, no images, no pdfs platform to make student’s life easier.
Unit II
Ethics In Clinical Research – Ethical issues in the conduct of clinical trials in India, Readiness of ethics committees, Independence of ethics committees, Training for ethics committee members. Informed consent process.
Unit III
Regulatory Affairs In Clinical Research – Roles & Responsibilities, Pharmacovigilance researching, assessing and evaluating information from healthcare providers and patients. Pharmacovigilance is particularly concerned with adverse drug reactions. Adequacy of regulations to safeguard the clinical trial participants.
Unit IV
For the complete syllabus, results, class timetable and more kindly download iStudy. It’s a lightweight, easy to use, no images, no pdfs platform to make student’s life easier.
Unit V
Clinical Trial Monitoring – Fundamentals of Clinical Monitoring, the processes and procedures of monitoring a clinical trial, Clinical, Pharmacological (including pharmacodynamics and pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of the new drug. Clinical Data Management And Biostatistics – establishment of protocol-specific data review and entry guidelines to document data validation and formatting procedures.
For detail syllabus of all other subjects of B.Tech Biotech, 2019-20 regulation do visit Biotech 7th Sem syllabus for 2019-20 Regulation.
Don’t forget to download iStudy for the latest syllabus, results, class timetable and more.