List of documents required for Ethics committee (EC) submission

There are two types of ethics committees(EC) available in India. These are Institutional ethics committee and Independent ethics committee. You can also see the more details about these two ECs here.  Here we have provided a list of documents required for Institutional ethics committee(IEC) for protocol review. Documents requirement also differ from each institutional ethics committees. It is defined according to their standard operating procedures(SOPs). These mentioned documents should be produced in ‘n’ number of sets. Along with these documents hard copies, soft copies should be copied to a CD (Compact  Disk) for reference.   

Overall required documents are as follows

List of Ethics committee documents

  1. Protocol
  2. Case record form
  3. Informed consent form or site specific informed consent form (English copy along with copies in Vernacular languages)
  4. Patient information sheet ( English copy along with copies in vernacular languages)
  5. Patient diary (English copy along with copies in vernacular languages)
  6. Investigator’s brochure
  7. Proposed methods for patient recruitment (Advertisements, Posters etc.)
  8. Clinical Trial Agreement
  9. Protocol signature page
  10. Investigator’s undertaking
  11. Principle Investigator’s Curriculum vitae
  12. Principle investigator’s medical registration certificate
  13. Principle Investigators No conflict of interest statement
  14. Study Insurance
  15. Letter of Indemnification

After completion of submission process along with processing fee cheque, EC will review the documents.

Note: A few ethics committees will have Scientific research society / scientific review board / scientific committees. They will screen and study the submitted documents then forward the project to Ethics committee.

Related: Types of clinical trials

EC will take final decision. Final decision will be decided by voting of ethics committee members. The decision may be anything. Usually types of responses will be given by an Ethics committee are

  1. Approved
  2. Queries raised
  3. Conditionally approved
  4. Rejected

Approved: It is a positive decision for sponsor or study personal. Letter will be issued with protocol number, version number and date. It includes all the details about attended members and list of documents reviewed. It also contains general rules. Those are like inform the progress of study/ Serious adverse events should be informed/ follow the ICMR/ ICH GCP/ Schedule Y guidelines/ study should be registered with CTRI etc. 

Queries raised: In this scenario, EC may raise the queries regarding the study from any point of view (patient safety/ study protocol etc.).

For eg.

1. Explain why ‘n’ numbers of blood tests will be done in short period of time.

2. Explain the rationality for studying the combination of these x and y drugs. Etc.

Receiving queries from the Ethics committee, sponsor need to respond with proper explanation. Required supported documents should be produced in front of EC in the next scheduled meeting with amendment fee.   

Conditional approval: In this case, Ethics committee is okay with the study procedure. EC may instruct that after fulfilling the particular requirement only, this approval is valid.

Rejected: If EC not at all satisfied with the study protocol including unethical procedures. EC may reject the study. Rejection letter will be issued with reasons..

B pharmacy interview exam for freshers Part 2

B Pharmacy interview exam:

Here we have given a model B Pharmacy interview exam paper for candidates who are looking for a b pharmacy fresher’s jobs in the pharmaceutical production plant and R&D. This exam contains only multiple choice questions or descriptive type questions or combinations of both. Model multiple choice questions are given here. Click here to view the part 1 questions

B Pharmacy interview questions

Answers all the (Each correct answer carry one mark)

1. Identify the falling height during the Tablet Friability testing?

a. 6 inches

b. 5 inches

c. 8 inches

d. 4 inches

2. Capsule sizes are given below. Which one is the bigger size form below given options?

a. 00

b. 0

c. 3

d. 000

3. Acceptable mean weight loss for the three tablets during the Friability testing is

a. 1%

b. 5%

c. 3%

d. 2%

4. Unequal distribution of a tablet color is known as

a. Double impression    b. Filming                 c .Mottling                   d.Capping

5. Which of the following quality control test is not conducted for parenterals?

a. Content uniformity test                 b. Leaker test           c.Clarity test          d.Dissolution test

6. Which of the following are used to test the tablet hardness?

a. Monsanto hardness tester

b. Strong cob tester

c. Pfizer tester

d. All of the above

7. What is measuring unit of tablet hardness?

a. Kg/cm2

b. Kg/cm3

c. %

d. Kg

8. Which of the following drug is a alpha + beta blocker?

a. Sotolol

b. Atenolol

c. Labetalol

d. Metoprolol

9. How much percentage of moisture present in empty capsule?

a. 33%

b. 10-15%

c. 50-70%

d. 80%

10. Pyrogen test is conducted for parenteral formulations. What is the minimum volume used for this test.

a. 5ml

b. 10ml

c.15 ml

d. 20 ml

11. Which of the following drug is used to treat malaria?

a.Terbinafine

b.Mefloquine

c. Nystatin

d. Famcilcovir

12. Which of the following class of drugs are not used to treat diabetes mellitus?

a. Sulfonylureas

b. GLP 1 agonists

c. DPP 4 inhibitors

d.Carbonic anhydrase inhibitors

13. Capsule sizes are given below. Which one is the smaller size form below given options?

a) 00

b) 0

c) 3

d) 000

14. What UltraViolet(UV) range?

a. 380 -750nm

b. 400 – 700nm

c. 190 – 380 nm

d. None of the above

15.  Which of the following dye solution is used for performing leaker test?

a.1% methylene blue

b. 5% methylene blue

c.10% methylene blue

d. 20% methylene blue

16. Aerosols storage condition is

a. Below 120 0F

b. Below 160 0F

c. Below 105 0F

d. Below 95 0F

17. Which of the following drug is a potassium sparing diuretic?

a. Furosemide

b. Indapamide

c.Acetazolamide

d. Amiloride

18. Pick out the standard number of rotations used for friability test?

a. 50

b. 200

c. 500

d. 100

19. What is the pH of blood”?

a. 25 – 7.35

b. 35 – 7.45

c. 15 – 7.25

d. 45 – 7.55

20. Acetyl salycylic acid is known as

a. Paracetemol

b. Aspirin

c. Ibuprofen

d. Ketamine

Answers:

1.a                     2.d                     3.a                    4.c                     5.d                 6.d                 7.a               8.c                  9.c                  10.c               11.b                 12.d                   13.c                  14.a                   15.a               16.a               17.d             18.d                19.b                 20.b

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