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.

How to search pharma jobs- Part 1

Search pharma jobs

Based on my experience I am giving you the ways to search pharma jobs. After getting known this information, if you try genuinely, definitely you will get the job. Along with the information am also providing the required urls (uniform resource locator).  So that you can easily redirect to that pages or websites etc.

Methods to search pharma jobs can be divided as shown below.

A. Offline

B. Consultancies

C. Online

A. Offline- by direct contact

First of all we will go through the offline ways, it does not necessarily mean that you are not using help of internet, but it means the major work done through offline.

1. Reference:

In this method, you will approach your senior/relative/friend who are already working in the pharmaceutical industry. You provide them your resume, they will forward it to Human Resource (HR) department. You will get an interview opportunity, if you succeed, you will get the job. Story ends.

2. Resume distribution:

You have to take print outs of your resume. You have to go pharma industrial area (where you will find at least 10-20 pharmaceutical companies) and give your resume to front office/security office. If they have any urgent /bulk requirement with your qualification, you will get an interview call. If you are okay in interview you will get the job. Story ends.

Note:  This is a tedious process. If you want to try this method, definitely you should go to any pharma/biotech industrial area on bike only. If you go on public transport, you can’t give more than 5/6 resumes in a day because pharmaceutical companies/plants are located far away from its next pharma company usually (200-400 meters distance from its next company). Some companies will not allow you to submit the resume. This is the worst experience we have ever faced.

search pharma jobs
3. Campus interviews:

If your college is good and have relationships with the employers, your first interview call will be offered from your college itself. But this percentage is very less.

4. Job fair:

These are usually conducted by Non profit organisations or colleges. Any body can attend this job or sometimes registration should be done. Care should be taken in job fair if you are going to pay money. There is no specific job fair conducted for only pharma people point of view. Pharma specific job fairs are rare. Job fairs usually conducted on colleges or grounds on specified dates.

Related: Clinical trials overview

Due to large number of students, they don’t have time to take interview. They will take resumes or contact numbers. Most of the times, non-technical jobs will be recruited by this way. If you need a technical job suitable for your qualification, you have to try other methods.

Related: B pharmacy interview questions

B. Job Consultancies

This a paid method. Other discussed methods in this website are free to use and there is no involvement of third party person apart from you and employer. Choosing a good consultancy is important in this method. Job consultancies has it’s own advantages and disadvantages.

Advantages:

If you find a good trusted consultancy,

You need not to do anything to get an interview call.

You will have freedom to choose your interested department.

No need to strain more to get the reference.

Disadvantages:

You have to pay money

There is a chance of cheating (For ex. Consultancies should have an official tie up with the employers. Some consultancies have an individual tie-ups with HOD/HRs (this is not a correct way) to recruit the employees. If everything goes good, no problem. Other wise recruited employees will be treated as a back door employee).

Note: If you are preferring this method, try to pay major portion of the charged amount after receiving the first month salary only. If you get the salary on time like other employees, It is a sign of official confirmation from your employer. 

Related: List of pharmaceutical companies in Hyderabad

This is the first part of how to search pharma jobs. Next part of ‘how to search pharma jobs’ discuss the online ways to search the pharma jobs.

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