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Clinical Trials Registration

Clinical Trial Registry Account SOPs

Request submission:

  1. The user account request on clinical trial registry will be submitted through prescribed form/google link (see below) to Mr. Mudassar Ali room no.278, 1st Floor. Phone Ext. 505 in hard and soft copy at the following email address: oric@cmhlahore.edu.pk      
  2. Faculty member of all constituent schools of CMH Lahore Medical College & IOD will be eligible to get an individual user account. Students’ protocols may be registered by their approved supervisor only.
  3. Only completed application forms will be entertained.
  4. Studies to be conducted by the faculty members for the award of any particular degrees, may be registered with the official account of the concerned degree awarding institute (DAI). If there are any limitations in this regard, the case may be evaluated separately and if data is to be collected at our research/Lab facilities, a user account may be created in that particular case.
  5. Completed applications will be forwarded to the committee for further processing.

 

Clinical Trial Registry Account Management Committee (CTRA-MC)

  1. Committee members are as follows:
  1. Dr. Wajida Perveen-  Focal person
  2. Director L-ORIC / Research Cell
  3. Chairperson Ethical Review Committee

Quorum of 50% of members is mandatory to review & make a decision on the submitted requests.

 

  1. Account details will be shared to the applicant in 5-7 business days.
  2. It is the responsibility of the account holder to keep the records updated.
  3. Registered study protocols should adhere with the ethical principles, relevant guidelines (DRAP guidelines, declaration of Helsinki etc) of the concerned regulatory bodies.
  4. In case any account holder leaves the institution, the account will be handed over to the focal person. It may then be assigned to a co-investigator who will lead the study or may be closed as deemed appropriate. (HR to include a clause in clearance form for L-ORIC, IT department to consult the focal person before closing the email account).
  5. Only those protocols, approved by CMH LMC & IOD ethical review committee will be published on protocol registration site (PRS).
  6. In case of collaborative research protocols, the consent of the other party will be advisable.
  7. Mr Muddassir to keep the record at L-ORIC.

 

 

Application form for user account on Protocol Registration Site (PRS) www.clinicaltrials.gov

Serial no.________________________________________________ (to be added by L-ORIC)

Full name: ________________________________  Designation: _________________________

Primary Appointment in Program: MBBS                   BDS                 ION                   SAHS____

Department: ___________________________________________________________________

Contract Expiry Date: ___________________________________________________________ 

Date of Joining at CMHLMC & IOD: _______________________________________________

ORCID (Mandatory):____________________________________________________________

Profile links (Please fill all applicable)

Google Scholars: _________________________________________________________

ResearchGate: ___________________________________________________________

Scopus: ________________________________________________________________

Any other not listed above: _________________________________________________

Title of the study/ Protocol to be registered: __________________________________________

____________________________________________________________________________________________________________________________________________________________

Principal Investigator: ___________________________________________________________

Co Investigators (if any): _________________________________________________________
Ethical Approval by_____________________________ (committee name), copy to be uploaded

Reference No: ___________________ Dated: ___________________ Valid up to: ___________

Official Email: ___________________________ Alternate Email: ________________________

Contact no: _____________________________ Alternate Contact no: _____________________

Link: https://docs.google.com/forms/d/e/1FAIpQLSeQpy36OC_TzQhyywit1yeIOSGIF30R1JE3lKnPU_h4EQPU3g/viewform?usp=header