Please find a summary further to a very collaborative meeting held Monday 11th February between DoH ( Pakiso and Lineo) and SACRA and IPASA representatives, to address the current backlog:
According to DoH they are on top of the backlog but it seems that there is a breakdown in the distribution of the approvals. We have agreed a way forward to address this.
They have tackled the backlog aggressively with staff working on the weekend again. Many permits have been processed and will be released Monday and Tuesday 11/12thFebruary. Leonard will be collecting these permits and distributing them through SACRA and IPASA to member companies to ensure rapid distribution.
Options for a more long term solution were also discussed and include an online application system with application fee and issuance of permits for the duration of the study.
Key points that need to be stressed to industry for any new applications:
All applications MUST go to e-mail address (firstname.lastname@example.org) – individual e-mail addresses for DoH staff must NOT be used
Approved permits are sent to the e-mail address specified on the permit so be sure this is the SAME as the person e-mailing the applications. Please see below where this is captured in the application
Even though there is not a specific field for the protocol/study number please can this also be included
Sponsors / CROs etc should identify ONE point of contact that makes all submissions
Key points that need to be stressed to industry for any errors on applications and applications that are not received in full e.g.: pages missing:
The applicant should follow-up immediately as the error is noticed by phone to have the permit re-issued. They should know the date, time and name of person who e-mailed application on hand to help traced the original application
ACTION for EVERY APPLICANT
Forward a list of outstanding permits FROM JAN 2018 to end JAN 2019 to Barbara Sematimba (email@example.com) for SACRA by COB Wednesday 13th Feb, using the previous template distributed.
PLEASE NOTE: ONLY applications that have been previously emailed to firstname.lastname@example.org may be included. It is each company’s responsibility to be sure and have proof of the original e-mail applications.
FYI-SACRA will be collating for CROs.
These lists will then be collated and the consolidated, verified list emailed to DoH by COB Thursday 14th Feb. We have got permission for two independent individuals (Barbara from SACRA and Zola from IPASA) to go to the DoH on Monday 18th with the list of outstanding permits and work with DoH staff to:
Check if they have been processed
Distribute appropriately to the sponsors / CROs
Identify the true outstanding permits where re-application may be necessary
This is a wonderful opportunity to collaborate with the staff and resolve the backlog. Please adhere to the deadline and refrain from calling DoH until after 22nd to allow the optimal efficiency.