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- 24 Apr 2021, 20:27
#4742
To report SAE on SUGAM portal, sponsor shall mandatorily follow the below mentioned steps to build-up the database and for proper linking of data.
Add Site Investigator
After login into the SUGAM portal,click on “Add Site Investigator” tab under “Clinical Trials”. Sponsor has to enter the Investigator’s basic details and click on “Submit” button.
On clicking Submit button, an e-mail link will be sent to Investigator for confirming and creating his login credentials. The User Id is auto fetched (i.e. same as entered by applicant/sponsor), investigator needs to enter only Password and Confirm Password.
Site Investigator Mapping
After the registration of Investigator’s User Profile, Applicant/Sponsor will map them with the trial Site/Hospital from his dashboard.
Applicant/Sponsor has to select the BE/CT application, a list of sites mentioned in the CT-NOC will get displayed. Just select the site investigator from drop down and check the checkbox (as highlighted) and click on “Save” button.
Initiate Clinical Trial
Once the Site Investigator mapping is done for any BE/CT application,the applicant/sponsor can initiate the trial.
Applicant/Sponsor has to select the BE/CT application and enter the CTRI Registration Number, thenclick on “Save” button.
SAE Reported
After the initiation of the clinical trial SAE occurring at any trial site has to be reported by investigator, sponsor and ethics committee involved in that particular clinical trial.
Add Site Investigator
After login into the SUGAM portal,click on “Add Site Investigator” tab under “Clinical Trials”. Sponsor has to enter the Investigator’s basic details and click on “Submit” button.
On clicking Submit button, an e-mail link will be sent to Investigator for confirming and creating his login credentials. The User Id is auto fetched (i.e. same as entered by applicant/sponsor), investigator needs to enter only Password and Confirm Password.
Site Investigator Mapping
After the registration of Investigator’s User Profile, Applicant/Sponsor will map them with the trial Site/Hospital from his dashboard.
Applicant/Sponsor has to select the BE/CT application, a list of sites mentioned in the CT-NOC will get displayed. Just select the site investigator from drop down and check the checkbox (as highlighted) and click on “Save” button.
Initiate Clinical Trial
Once the Site Investigator mapping is done for any BE/CT application,the applicant/sponsor can initiate the trial.
Applicant/Sponsor has to select the BE/CT application and enter the CTRI Registration Number, thenclick on “Save” button.
SAE Reported
After the initiation of the clinical trial SAE occurring at any trial site has to be reported by investigator, sponsor and ethics committee involved in that particular clinical trial.
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