1 Registration *Note: Membership to this portal is Private. Once your account information has been submitted, the portal Administrator will be notified and your application will be subjected to a screening procedure. If your application is authorized, you will receive notification of your access to the portal environment. All fields marked with an asterisk (*) are required.

2 UPDATE  69 Applicants Registered on the NHREC Site This includes Contract Clinical Research Companies; Investigator Driven Research; and Private Research This includes Contract Clinical Research Companies; Investigator Driven Research; and Private Research  69 Registered on the SANRR Site Re-entry of confirmed and verified data from NHREC Re-entry of confirmed and verified data from NHREC  169 Studies / Trials Registered (growing daily) 34 have confirmed DOH numbers 34 have confirmed DOH numbers 121 Still to be submitted to SANRR 121 Still to be submitted to SANRR Delay in receiving balance to SANRR register Delay in receiving balance to SANRR register Awaiting approval from IEC / MCCAwaiting approval from IEC / MCC Trial captured and not submittedTrial captured and not submitted Trial captured but not complete and applicant waiting for data before submittingTrial captured but not complete and applicant waiting for data before submitting

3 HELP DESK SUPPORT  231 S received on NHREC and SANRR  200 Average of 1-2 Phone calls per for verificiation of data Corrected and confirmed dataCorrected and confirmed data Follow-up callsFollow-up calls  3-5 Average of phone calls or s per Applicants in support some users required more than that!some users required more than that!

4 HOW TO REGISTER  USER NAME o IMPORTANT that ‘USER NAME’ is standard o Not advisable to use - Personal name; ID No, Student number; cryptic name. o For ease of reference for example use: 1. Register under Company Name 2. Academic Sites Register under University and department o To enable website portal to group data under ‘USER NAME’ for future reference by the Company / Sponsor / Investigator / Head of Department etc.

5 IMPORTANCE OF PASSWORDS  PASSWORD Please use generic ‘PASSWORD’ – keep in safe place and only make available to the relevant people within your Company eg Please use generic ‘PASSWORD’ – keep in safe place and only make available to the relevant people within your Company eg People involved in the capture of Trials / StudiesPeople involved in the capture of Trials / Studies Clinical Research DepartmentsClinical Research Departments Senior members of Company should have access to this and be updatedSenior members of Company should have access to this and be updated  PASSWORD PROTECTION Should the person responsible for the capture of the information on the website within your company relocate or resign it is Should the person responsible for the capture of the information on the website within your company relocate or resign it is vitally important that the password be updated on both websites. vitally important that the password be updated on both websites.

6 How to Register Step 1: NHREC  The trial information required for the SANRR register is coordinated through the initial ethics application process. Industry/Pharmaceutical Co/Sponsor responsible to register and complete study information : (Clinical Drug Trials / Device/ Vaccine and other interventional studies ) Industry/Pharmaceutical Co/Sponsor responsible to register and complete study information : (Clinical Drug Trials / Device/ Vaccine and other interventional studies ) Investigators / Researcher initially capture trial details on-line : (non-clinical studies) Investigators / Researcher initially capture trial details on-line : (non-clinical studies)  Go to ABOUT – click on HOW TO REGISTER – please read all information  Click on the REGISTER button on the top right hand side of the screen;  Username should be generic to a company / division / department  Fill in all details and then click on the REGISTER button at the bottom center of the screen (RTS - READ THE SCREEN *NOTE)  You will receive a phone call from portal administrator verifying your details.  As soon as your registration is authorized, you will receive notification of your access to the portal environment via .  You will then be able to ‘login’ under user name and password - go to Capture Trial on the NHREC site register study – print copy of NHREC application and hit the ‘submit’ button  Please print out the NHREC application registration form and attach a copy to your Ethics Application Standardization Form – submit to your accredited research ethics committee

7 SANRR –  The portal administrator will register your details on the SANRR site and notification will be sent via confirming your registration User Name will be same as on the ‘ethicsapp’ site User Name will be same as on the ‘ethicsapp’ site Password selected by Portal Administrator Password selected by Portal Administrator Once notification has been received that you have been registered on the SANRR site please ‘update’ password. Once notification has been received that you have been registered on the SANRR site please ‘update’ password. Step 2:  ONLY once Ethics Regulatory Approval / MCC approval has been received are you then required to go onto the SANRR site and register your study using your NHREC application number. (generated by system)  Should all relevant information be correct The DOH – SANRR will respond via with the DOH approval number  Applying for DOH - SANRR number is done at site.  User - ‘Login’ using login details obtained via the SANRR portal administrator  Select the ‘SANRR Toolkit’ button to enter Regulatory Approval information required to request a SANRR (DOH) Number

8 Step 3:  The NHREC data is then uploaded automatically to the DOH help desk where the SANRR Number is allocated.  Receipt of the SANRR Number provides the research team with the authority to commence with the study.  The SANRR number will be generated within two (2) working days. This will be done either by or fax and will be sent to both the relevant research ethics committees and the applicant. Step 4:  Those studies that require additional registration with the Medicines Regulatory Authority, after ethical clearance, will be entered onto both the MCC database and the SANRR. Confidentiality related to the regulatory process will be observed.

9 South Africa National Research Register Department of Health (DOH)  Apologies from Khethani Hlongwa for not being able to attend due to prior commitments in Durban  Request that we extend their appreciation to all those who have used the register  DOH anticipating the regulations legislating mandatory registration to be passed within the next few months and trials that commence without registration will be illegal  Khethani’s contact details:  SANRR website address

10 Delays in receiving DOH number? National Budget Amount required to be completed National Budget Amount required to be completed Request from DOH - it appears applicant hesitant to complete info, but government uses information to identify neglected areas and advocate for research in the area that has been identified to be a priority. Importance to budget, even if it is a calculated estimate.Request from DOH - it appears applicant hesitant to complete info, but government uses information to identify neglected areas and advocate for research in the area that has been identified to be a priority. Importance to budget, even if it is a calculated estimate. Information missing from data required by the DOH is having to relevant person for an update of the information Information missing from data required by the DOH is having to relevant person for an update of the information Update can only happen on the Ethics App site under ‘Edit Trials’ Update can only happen on the Ethics App site under ‘Edit Trials’ Avoid delays by completing the required fields Avoid delays by completing the required fields Contact person for public directory still under discussion, DOH looking at option for an address for the public rather than a contact person– this is still under development Contact person for public directory still under discussion, DOH looking at option for an address for the public rather than a contact person– this is still under development Applicants encouraged to state the entire inclusion / exclusion criteria – this information becomes publicly available. To avoid unnecessary calls from the public asking if they qualify. Applicants encouraged to state the entire inclusion / exclusion criteria – this information becomes publicly available. To avoid unnecessary calls from the public asking if they qualify. Inconsistent information: Inconsistent information: Anticipated start date – aware there is delay with approvals – try to avoid using a past anticipated date! egAnticipated start date – aware there is delay with approvals – try to avoid using a past anticipated date! eg Application sent in March with anticipated start date August 2005? Application sent in March with anticipated start date August 2005?

Thank you Sub-contrators to run ‘helpdesk’ for the NHREC and DOH -SANRR