MCQ of Non-graded Assignment (SWAYAM) PDF

## Week 2: Assignment (Non Graded) - Assignment not submitted - Note: This assignment is only for practice purpose and it will not be counted towards the Final score 1) Which Rule governs the inspection of premises relating to the clinical trial site? shall allow any officer authorized by the __...

## Week 2: Assignment (Non Graded) - Assignment not submitted - Note: This assignment is only for practice purpose and it will not be counted towards the Final score 1) Which Rule governs the inspection of premises relating to the clinical trial site? shall allow any officer authorized by the ____ who may if considered necessary, be accompanied by an officer authorized by them ____ to enter the premises and clinical trial site with or without prior notice to inspect, search or seize, any record, etc. - Rule 27, SLA and CLA - Rule 28, SLA - Rule 29, CLA and SLA - Rule 30, CLA * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * Rule 29, CLA and SLA 2) Which type of oral drug formulations is suitable for BA/BE study? - Systemically absorbed, sustained-release /IR - Rapid absorption in the blood - Topical drug - Injectable drug * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * Systemically absorbed, sustained-release /IR 3) State true or false: Bioavailability or bioequivalence study of a new drug or investigational new drug is regulated by the Central Licensing Authority (CLA). - True - False * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * True 4) Which are the main criteria(s) for 'predictable toxicity' of the drug "Linezolid", an antibacterial drug of the oxazolidinone class. Activity against Gram-positive organisms including some resistant organisms. The main criteria for predictable toxicity are : - Myelosuppression was identified as possible toxicity in non-clinical studies - bone marrow hypocellularity - decreased extramedullary hematopoiesis - decreased levels of circulating erythrocytes, leukocytes, and platelets - All of the above * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * All of the above 5) Name some Phyto-pharmaceuticals drug approved in India. - Quinine - Silymarin - Paclitaxel - Arteether - All of the above * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * All of the above ## Week 3: Assignment (Non Graded) - Your last recorded submission was on 2024-09-20, 22:59 IST - Note: This assignment is only for practice purpose and it will not be counted towards the Final score 1) _____________ is an inactive substance visually identical in appearance to a drug being tested in a clinical trial? - Audit trail - Investigational Product - Informed consent - Placebo * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * Placebo 2) What are the validity period and renewal of registration of the BA/BE study centre? - 5 Years and 90 days - 2 years and 45 days - 1 year and 30 days - 3 years and 60 days * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * 5 Years and 90 days 3) State true or false: Bioequivalence studies are not necessary if the new drug is to be administered parenterally. - True - False * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * True 4) The guidelines for BA/BE studies were introduced in India by CDSCO in ______________. - 2000 - 2001 - 2004 - 2005 * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * 2005 5) State true or false: The platelet aggregation inhibitor, Clopidogrel is pre-systemically hydrolyzed to the inactive metabolite Clopidogrel carboxylic acid. The plasma levels of the unchanged drug are up to 2000 fold lower than those of the carboxylic acid metabolite. Another metabolite, Clopidogrel thiol, formed by a parallel pathway, is the pharmacologically active form of Clopidogrel and is generated in the intestine and liver primarily by the CYP2C19 enzyme isoform. Due to its chemical instability and low circulating levels, its detection in plasma is problematic. - True - False * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * True ## Week 6: Assignment (Non Graded) - Your last recorded submission was on 2024-09-02, 10:23 IST - Note: This assignment is only for practice purpose and it will not be counted towards the Final score 1) What is meant by a blind subject? - Subject is blind - Fake treatment - Investigator and Ethics Committee are blind - The subjects do not know which study treatment they receive * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * The subjects do not know which study treatment they receive 2) State true or false. New studies specifically planned or conducted to examine a safety issue should be described in PSUR. - True - False * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * True 3) Fill in the blanks: Periodic Safety Update Reports due for a period must be submitted within __________ of the last day of the reporting period. - Ninety calendar days - Ninety days - Thirty calendar days - Thirty days * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * Thirty calendar days 4) State true or false: Any change to the protocol document or Informed Consent that affects the scientific intent, study design, patient safety, or human subject protection is considered a deviation, and therefore must be approved by EC and Regulatory Authority. - True - False * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * False 5) Which of the following is a mandatory requirement in a clinical trial protocol as per the NDCT Rules, 2019? - Study objective - Study synopsis - Statement of compliance with GCP - All of the above * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * All of the above ## Week 7: Assignment (Non Graded) - Your last recorded submission was on 2024-09-11, 19:14 IST - Note: This assignment is only for practice purpose and it will not be counted towards the Final score 1) All the clinical trial applications in form -04 along with fees and dossier as per Table -1 as per NDCT Rules, 019, uploaded to ______________. - CDSA Portal - NPTEL - SUGAM Portal - CTRI website * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * SUGAM Portal 2) Inspection of premises relating to clinical trial is covered under Rule number ______________. - Rule 26 - Rule 27 - Rule 28 - Rule 29 * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * Rule 29 3) State true or false: Scientists determine the drug's stability in the formulation itself, and for all the parameters involved with storage and shipment, such as temperature, humidity, light, and time. - True - False * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * True 4) The Inspector from the regulatory agency (CDSCO here) is looking for ______________ when inspecting a clinical trial site or a BA or BE Centre. - Personnel - Premises - Processes - All of the above * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * All of the above 5) Inspection deficiency or deficiencies observed during a CT/BA/BE centre ______________. - Qualification of manpower involved - Training, evaluation, and assessment - SOPs, training, and equipment - All of the above * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * All of the above ## Week 8: Assignment (Non Graded) - Your last recorded submission was on 2024-09-17, 21:28 IST - Note: This assignment is only for practice purpose and it will not be counted towards the Final score 1) What is SUGAM? - Suraksha in Government Administration & Management - Secure Unsecure Governance Administration & Management - Suraksha Gunvatta Avam Maanakta - None of the above * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * Suraksha Gunvatta Avam Maanakta 2) State true or false: The 'new definition' of 'Investigational New Drug' (IND) is that it is a new chemical entity or a product having a therapeutic indication but which has never been tested earlier on human beings. - True - False * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * False 3) State true or false: Countries that do not have a Primary Registry of their own may also register in the CTRI. - True - False * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * True 4) Fill in the blanks: Initiated as a voluntary process, registration of regulatory interventional trials in the CTRI was declared ______________ by the DCGI, CDSCO in ______________. - Mandatory; 2009 - Voluntary; 2009 - Mandatory; 2013 - Voluntary; 2013 * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * Mandatory; 2009 5) State true or false: Earlier regulations and Schedule Y is still applicable to all the veterinary drugs in India. - True - False * **Yes, the answer is correct.** * **Score: 1** * **Accepted Answers:** * True Your score is: 5/5.