List of documents required for Ethics committee (EC) submission

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February 28, 2023

6:00 am

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Clinical research, M Pharmacy freshers

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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 1

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April 29, 2020

6:53 am

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B Pharmacy freshers, Pharma fresher's guide, Pharmacy interview questions

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B pharmacy job selection process

The job selection process of pharmaceutical companies varies from company to company. Depend upon the company, you may appear for the B Pharmacy interview with or without writing a qualifying exam. Usually the reputed pharmaceutical companies conduct a qualifying exam before  selecting for interview. This qualifying exam will helps them to assure that the job aspirant is having minimum basic knowledge about the subject. As well as it helps to reduce the number of candidates appearing for interview.

For eg: 20 positions(Jobs) are available. But 300 candidates came to the interview location. Exam conducted for all the candidates; then top 60 or top 80 graduates selected for the interview based on the marks. Now the Job selection process is based on 1:3 or 1:4 ratio. Out of 3 or 4 candidates they offer job for one candidate.

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.

b paharmacy interview exam

Answer all the questions (Each correct answer carries 2 marks)

  1. Write the chemical names?
    • a. Vitamin B6
    • b. Vitamin B12
  2. Write any two lubricants, which are used in tablets manufacturing?
  3. Write the abbreviations of IP and BP?
  4. What is friability test and how to calculate it?
  5. What are the steps involved in wet granulation process?
  6. Define API and explain it?
  7. Write any two types of formulations and explain it?
  8. Name any two sources of Vitamin C? Write any disease caused by vitamin c deficiency?
  9. What is oxymel?
  10. Expand the UHPLC, TLC, LVP and SVP?

Answers:

1)

  1. a) Vitamin B6- Pyridoxine
  2. b) Vitamin B12 – Cyanocobalamin

2) Commonly used lubricants are Talc, silica, Stearic acid and Magnesium stearate etc

3) IP full form Indian Pharmacopoeia

BP full form British Pharmacopoeia

4)  Friability test is conducted to know the physical strength of a tablet. It is the withstanding capacity of a tablet when it is on manufacturing and transportation.

It is calculated by using this formula

Friability =(Initial weight- Final weight)/Initial weight * 100

Initial weight in mg- before test

Final weight in mg- after completion of test

5) Following steps involved in the wet granulation process

  • Mixing
  • Drying
  • Dry screening
  • Fluid bed granulation

6) API is known as Active Pharmaceutical Ingredient. First and most important component of any formulation. There is no finished dose formulation is available without having an API.

7) Various types of formulations are available

Topical formulations:

This type of formulations are administered by local route, applied on the skin. The active ingredient in formulation does not enter into the systemic circulation.

e.g Topical creams

Parenteral formulations:

These formulations are administered by the parenteral route that in to blood. The ingredients in the formulation is directly enter in the blood. Bioavailability is high for this formulations.

ex: Intravenous Injections

8)  Oranges, Lemons and Tomotos are sources for vitamin C. Severe deficiency of vitamin C causes “scurvy” disease.

9)  Oxymel is a mixture of honey , water and vinegar.

10) UHPLC is known as Ultra High Performance Liquid Chromatography.

LVP is known as Large Volume Parenteral

SVP is known as Small Volume Parenteral

You can visit continuation of this questions and answers here.

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