SOP NO.2: Standard Operating Procedure for Managing a Protocol Submission

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SOP NO.2: Standard Operating Procedure for Managing a Protocol Submission


To describe how a research protocol submitted by investigators is processed before review by the committee.


This SOP applies to

  • protocol packages submitted for the first time to NCRSH for review
  • NCRSH members and secretariat
  • Investigators

Allowable Exceptions

This SOP is meant to be followed without deviation

Specific Procedures

  • Secretariat writes an acknowledgement letter of receipt of the package
  • Secretariat conducts administrative screening of the application package against the NCRSH checklist within two working days
  • Secretariat informs investigator/applicant whether application package was complete or incomplete within the two working days by telephone and e-mail after administrative screening
  • If application package is incomplete, investigator is required to provide the missing documents/information within five working days after notification of the incompleteness of the package. If the missing information is not provided within the stipulated five working days, the application package automatically gets rejected. The applicant, however, has the liberty to make a fresh submission of the package.
  • On acceptance of the completeness of the package, secretariat
  • assigns protocol  reference number
  • puts the protocol on register and database
  • assigns the review date for the protocol and informs the investigator that protocol has been accepted for review
  • NCRSH Chairperson and secretariat assign the primary, secondary and third reviewers of the protocol based on expertise in the subject area of the study.
  • Secretariat submits package to reviewers 15 days before the date of the full committee meeting, if such a protocol is to be reviewed through an ordinary full committee review procedure (SOP NO.3) which is quarterly (i.e every three months), otherwise an expedited review procedure may be followed as per SOP NO.4.

Definition of Terms

Protocol package: The set of documents that includes the protocol/proposal in the required format and other relevant documents submitted by the investigator when applying for approval from NCRSH. The package should comply with the submission requirements as detailed in the NCRSH checklist.