Update on March Meeting with NDoH

March 20, 2020

 

Dear SACRA Associates,

 

As we had promised at the beginning of 2020, we shall be providing you with updates on our on-going monthly meetings with the National Department of Health (NDoH).

 

SACRA Exco had a meeting this week with the Biological Permits Unit at which we were following up on any pending permits as well as to discuss the operational developments of this Unit in meeting timelines.

SACRA also presented specific pending permit cases brought to our attention over the past month, as well as some general queries that you had sent us in order to get directive and clear answers to guidelines or regulations that were not clear to you.

 

This is the feedback from that meeting with the questions highlighted in bold:

 

 

1.Do we have some more information on the DoH data base registration for PIs?

  

This data base is far from being completed and therefore no registration is to be done. No collection of data is expected to be done any time soon.

The PI Register form should never have been released to the Industry in the first place.

So, we have been asked to essentially ignore the form until proper guidelines are in place, providing clear instruction on the process of this registration.

The NDoH has apologised to industry for the premature release of this document. 

 

 

 

2. Pending permits since 2019:

The Permits Unit would like to emphasis that incorrectly filled out forms or the incomplete forms, are more often that not, the reason why there exists the problem of pending permits.

In some cases, the application is missing a signature or the Site name details as requested on the form.

 

Me Dineo has requested that in order for these flagged permits to be followed up, can the actual original application form be sent as email attachment from a fresh email to Lineo, and not to simply forwarding the application as made in 2019 or whenever it was initially sent. If the same email is simply forwarded to the import/export NDoH address, it will appear with the same subject and title as initially sent and it cannot be flagged as a new email, as once opened, that application is considered attended to. 

So, the person following up should open up a new email with new subject line and send directly to her and attach the initial application form. 

email to use for this: lineo.Motopi@health.gov.za

 

3. On Duplicate permits sent from NDoH to the Applicants:

Often times, a Site has had multiple people from the Site/CRO/Pharma contacting the Permits unit, often in a frenzy for the same permit and may keep calling and emailing several times. The same permit may therefore receive multiple responses from each of the many staff that have been charged to respond to the same permit.

Applicants should therefore streamline their communication to the Permits Unit and not allow everyone to follow up on this as this creates the duplication of work that is both time and resource wasting.

 

4. Should the Site or PI's name be listed on the Export/Import form?

    Do we complete these with investigator site address, or may we add the institution? 

The permit is requested for and needed by the individual PI/Site as they are the practitioners that are dispensing the biological samples. 

So, it is these details that are required on the application form, and whether they are then working in conjunction with another institution or CRO or Institution is irrelevant, as these third parties are not directly responsible for the samples.

The Permit is PI specific then Site details for contact/address.

It is indeed the PI that owns the samples so PI name is on the form.

 

PLEASE DO SEND IN YOUR QUERIES, CONCERNS OR INDIVIDUAL PENDING PERMIT INFORMATION TO BE FOLLOWED UP AT THESE MONTHLY MEETINGS, EVEN AS YOU REMEMBER TO FILL IN THE TRACKER FOR PERMITS AND PROTOCOL SUBMISSIONS.

WE ARE DEPENDANT ON YOU FOR THIS DATA TO BE FILLED OUT ON THE TRACKER WE SHALL CIRCULATE, AS WELL AS ON THE SURVEY THAT WE ARE DRAWING YOUR ATTENTION TO PARTICIPATE IN OVER THE NEXT FEW WEEKS.

 

Thank you

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