The integrated addendum R2 to ICH- GCP E6 will come into effect in Switzerland on May 1st, 2017, with the revision of the annex 1 to the Ordinance on Clinical Trials.
Meanwhile, all GCP courses recognized by swissethics have been updated to the integrated addendum R2. Starting May 1st, a note about the requirements of the integrated addendum R2 will be added to the ‘decision letters’.
The launch of SNCTP2, which allows an automatic transfer of the clinical trials from BASEC to the SNCTP2 and includes an improved search function for the general public had to be postponed from February to end April - early May 2017. Before launch the internal FAQ will be updated with information about the workflow.
The use of harmonized template ‘decision letter’ is mandatory starting June 1st, 2017.
The template in DE and FR has been updated with following sentence to match the version in IT:
- “Die Auflagen sind innert 30 Tagen zu erfüllen und in jedem Fall vor der Rekrutierung des ersten Patienten.”
- “Les conditions doivent être remplies dans un délai de 30 jours et avant le recrutement du premier patient.“
Questions: Which ordinance is applicable to studies done with NM and/or NEM? Should the NM and NEM be made according to the requirements set in GMP or to the requirements set in the Foodstuffs Act (Lebensmittelgesetz LMG; Loi sur les denrées alimentaires, LDAl; Legge sulle derrate alimentary, LDerr)?
During the ‘Exchange meeting’ with Swissmedic and the FOPH on April 6, the following has been agreed: (Note: The decisions concern NM and NEM that can be placed on the market only [“authorized NM/NEM”: das Lebensmittel ist verkehrsfähig; le produit peut être commercialisé en tant que denrée alimentaire]):
- A study, in which a NM/NEM is compared to a NM/NEM, is a clinical trial as per ClinO, Chapter 4, Other Clinical Trials, Art. 60-61. The NM/NEM must be made in compliance with the requirements set in the Foodstuffs Act (Lebensmittelgesetz LMG).
- A study in which a NN/NEM is compared to a pharmaceutical product is a clinical trial (ClinO).
- If the criteria for the pharmaceutical product qualify for a category B clinical trial, the study must be submitted to Swissmedic and the NM/NEM must be made fulfilling the requirements set in GMP.
- If the criteria for the pharmaceutical product qualify for a category A clinical trial, the NM/NEM must be made fulfilling the requirements set in in the Foodstuffs Act (Lebensmittelgesetz LMG).
- The triage is made by the Ethics Committees.
- Scale of fees. The rules, which had been removed from the latest version of the scale of fees (version August 16, 2016) had been added back to the document as page 1. The scale of fees (page 2) did not change.
- New version: Concept Multicenter trials: deleted the obligation for the Applicant/sponsor to send to the EC the wet-ink signed ‚Research application form’.
In preparation: New version Template for the Declaration of end of study (it will be released by the end of the week latest; ICF ClinO and ICF HFV with persons with amended paragraph ‘liability’ and other minor changes.
- New version: The list of recognized GCP courses / GCP certificates issued before December 2015, has been updated with following text: “swissethics strongly recommends that the knowledge is maintained by regular research activity, e.g. by conducting clinical trials, attending continuing education related to research or GCP refresher courses, being exposed to GCP inspection etc.
The Ethics Committees can request the researchers to re-take a GCP course, if the Ethics Committees consider the knowledge has not been maintained.”
- In addition to ‘technical support request’ and ‘jurisdictional inquiry’, the users can now pick the form ‘General questions’ for submitting to the EC general questions about regulations/laws and about the submission of projects.
- A template has been created by Tobias and Dorothy to specifically address the key questions of a Jurisdictional inquiry: clarification of responsibility (‘Zuständigkeitsabklärung’, ‘Clarification des compétences’, ‘Esame della competenza’). The users can download the template directly from the page ‘jurisdictional inquiry/support request’. Its use is highly recommended but not mandatory.
- PB studies: fields for a classification of the study by type of study/clinical trial and risk category for the requestors are now available on the PB form. The classification of the PB studies by the requestors is optional.
- Section 39 (Miscellaneous / Varia) on screen 6 can now hold up to 20 documents (it could hold 10 before).
- TOOLBOX – Assigned Tasks: There is a new gear icon for each task which allows to open the project in a new tab/window, without having to leave the Assigned tasks view just to peek at one specific task.
- Such a gear icon was also added for the search result list: again, with this addition it’s possible to open a result (= found project) in a new window without losing the list of projects (search results).
- The Gantt-View for tasks is now directly accessible from the TOOLBOX-Menu.
The new PW-policy for the BASEC Back-end users will come into force on April 20, 2017. We invite you to change your PW before the deadline.
Remember to inform the ‘admins’ (Michael, Arthur or Pietro) about people leaving or joining the EC, either office staff or EC members. BASEC must be updated accordingly.
All key decisions taken by the board, by the ‘Ausschuss’ (restricted committee) and by other committees are compiled and summarized in an excel Pivot table which are available to the Presidents and the Scientific secretary on the cloud (link to the cloud here).