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Submission of Research Protocol (s) on Large Animals
Any establishment conducting experiments on large animals is required to send the protocols to O/o CCSEA for their approval.
Note: The establishments are required to get their Animal House Facilities approved and registered/renewed for housing large animals before commencing any research on them.
List of requisite documents for protocol:
1. Checklist of the Protocol (Completely filled and duly signed by the Principal Investigator).
2. Completely filled form ‘B’ (Section I & II) duly signed by the Principal Investigator alongwith Investigator’s declaration and Certificate (signed by Main Nominee of CCSEA and Chairman of IAEC).
3. Minutes of the IAEC meeting with the signed attendance sheet, wherein the protocol has been recommended by the IAEC and forwarded to CCSEA for approval. The IAEC meeting should be conducted with all the approved IAEC members, wherein the presence of CCSEA nominee and Socially Aware Nominee is mandatory. In case the Main Nominee conveys his/ her unavailability, Link Nominee may be invited in place of Main Nominee.
4. Rodent Study Data (wherever required).
5. The establishments are required to deposit the fee for Research Protocol through ‘online payment gateway’ as per revised fee (Rs. 1000/-for educational Protocols and Rs. 5000/-for non-educational Protocols) in the prescribed column at the time of the submission of Research Protocol (s) online.
Ø No Hard Copies of any of the above documents are to be submitted until asked for.
Ø All the formats (Checklist, Form B, format of Investigator’s declaration and Certificate, Format of Rat Study Data) are available on the website: http://cpcsea.nic.in/Content/53_1_FORMS.aspx.
Note: “The research protocols dealing with withdrawal of or below 0.6ml/kg body wt. of blood from large animals on weekly basis for the purposes of the experimentation on feeding trials, breeding experiments and live-stock management studies which require blood collection from the experimental animals to further study the clinical parameters and for the purpose of clinical disease diagnosis, field studies or thesis studies, may be approved by the IAEC. This will be applicable for ICMR, ICAR, Veterinary and Agriculture Universities and Government funded institutions handling large animals.”
Procedure for Submission of online Protocol:
Step1: The user is required to login through User Login Window at Home Page by selecting ‘Establishment Login’ in User type and put the User Name & Password which is given to each establishment(s) registered with CCSEA.
Step 2: Click on the Tab viz. New Research Protocol; a form will display wherein requisite details to be filled for submission of Research Protocol such as title of the protocol, details of species etc.
Step 3: Upload the requisite files in the above form such as Checklist, Form B, Investigator Declaration, Certificate, Minutes of IAEC meeting, Rodent Study data (if applicable) and Guidelines/ References related to your research protocol. (The maximum size of each file is displaying in front of the column)
Step 4: Tick in front of the IAEC members who have attended the IAEC meeting and recommended the research protocol to CCSEA for approval (Ensure the required quorum of the IAEC meeting as per the CCSEA guidelines and the presence of CCSEA nominee and Socially Aware Nominee).
Step 5: Click on Submit Button, After submit, payment detail page will display; Click on Make Payment and pay the requisite fee through online payment mode i.e. Debit Card, Credit Card and Internet Banking.