The integrated addendum R2 to ICH- GCP E6 entered the implementation period (= step 5) in November 2016. GCP E6 (R2) was adopted in Europe by the Committee for Medicinal Products for Human Use (CHMP) of the EMA on 15 December 2016. In Switzerland, the revision of the annex 1 to the Ordinance on Clinical Trials is expected for May 2017.
The SNCTP2 is an upgrade of the known SNCTP. The upgrade will allow an automatic timely transfer of the clinical trials registered in BASEC to the SNCTP2 repository. It will also offer an improved search function for the general public. The launch is planned for mid-end February 2017.
During the course of 1Q17 the ECs of Zurich, Vaud, Ticino and EKNZ will join the ECs of Bern, Geneva and EKOS and charge using the scale of fees of April 19, 2014 (updated on August 16, 2016).
An insurance certificate is accepted if it covers the whole study period. That is: from study start to study end in Switzerland. ‘Study start’ being defined as ‘first patient in’ at the first site in Switzerland and ‘study end’ being defined as ‘last patient last visit’ at the last site in Switzerland.
The insurance is not accepted if the period covered by the insurance ends before study start (i.e. first patient in) in Switzerland. In this case the sponsor must submit an insurance certificate with an extended validity.
The insurance is accepted if the certificate has a duration that is shorter than the study period, but the first patient was included in the study during the period of validity of the insurance and the insurance states that ‘The trial started during the period for which the contract is valid is in all cases insured until the completion thereof (and for the duration of coverage for long-term damage), regardless of the non-renewal of the insurance policy’. The sponsor shall inform the EC about the inclusion of the first patient.
1. Time span to meet the charges (‘Auflagen / charges / requisiti’):
The charges must be met no later than 30 days.
Pending final signed contract is a charge. Thus, the final signed contract must be submitted to the EC within 30 days. The Lead EC (not the local EC) is responsible to check the charge has been fulfilled.
The Applicant/sponsor is no longer required to send the wet-ink signed ‚Research application form’. BASEC and the ‚Research application form’ have been updated accordingly. The Applicant can still generate a PDF of the form for his personal use.
All key decisions taken by the board, by the ‘Ausschuss’ (restricted committee) and by other relevant instances 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).
1. Training modules on the Human Research Act and the Ordinances (an update to Newsletter 2016/9):
The online training TRREE does now issue a certificate of participation for the Swiss module. That is, participants to the TRREE should now be able to document their training with two certificates, one certificate for the GCP modules and one certificate for the Swiss module.
To avoid any confusion with the so called “delegation log”, following explanatory text has been added next to the template “staff list”.
Note: The ‘Staff list’ should be used in accordance with the Ordinance on Clinical Trials (ClinO) Annex 3 (1.10, 2.11, 3.9, 4.4) and with the Ordinance on Human Research with the Exception of Clinical Trials (HRO) Annex 2 (1.8, 5.11, 7.9). The ‘Staff list’ is not to be confused with the ‘delegation log’ as per ICH-GCP E6 4.1.5.
3. New Templates, new Versions:
- New version Template for the Declaration of consent (studies with children and adolescents), in German, French and Italian (v2.0): added signature box for parents/legal representative, removed option to non-inform the GP and how to deal with fortuitous findings.
- New versions Informed Consent Forms ClinO (v4.3 German, v4.4 French, v4.4 Italian): minor grammatical corrections and changes to improve the coherence between synopsis, main body text and signature page.
- New version Informed Consent Form HRO (v1.6, Italian only): minor correction/typos.
- New version Guideline and reminder for Swiss specific requirements in study protocols (v1.4): we removed the reference to Swissmedic for the requirement ‘Double contraception method’, which is no longer traceable.
- New version Clinical Study Agreement (last revision Nov 2016):we removed from the template the Exhibit: Study Protocol.
In preparation: New version (2.0): Template for the Declaration of end of study
1. New features
1.1. In preparation: In order to facilitate the communication between Applicant and the EC, in particular when the former need to submit urgent safety documents but the project is closed, it has been decided to allow the Applicant to start an Email-conversation with attachments. The Applicant will be able to do so using a link below the project in ‘Manage my applications’, but it can’t send messages by this method, if the project wasn’t submitted at least once.
Messages sent this way will be received by the ‘Project leader’. If there is no ‘Project leader’ set to a project, the email will be dispatched to the ‘Secretariat’ of the (Lead-) EC, by default. You can add and change the ‘project leader’ anytime (more detailed information on the various options available to the EC to set the ‘Project leader’, e.g. a team, a person, or an ‘individual’ within a team, will be made available in a FAQ before this feature is activated).
- To note: this feature breaks security/privacy in the following way: messages are not only sent through the portal (which is secure), but are then also sent out from BASEC to the Project-Leader's email (the email s/he uses for his/her login into BASEC), which has lower security standards than any transaction within BASEC.
You will be notify in advance when it this feature goes live.
1.2. In the Pre-BASEC backend form, the documents in the rooster ‘Docs’ can be ordered by upload date, date of doc. and version nr. This feature will be available in the main BASEC backend form shortly, where the documents could also be sorted by category, e.g. by cover letter, protocol, informed consent, …
1.3. File Manager: From the ‘Overview’ page of a project you can now go directly to the ‘File Manager’ with just one click.
1.4 Sticky notes: New display for the sticky notes. Select ‘sticky note’ under ‘internal extra fields’, do not select ‘sticky note Lead EC’.
2.1. In BASEC, the Applicants are asked to submit the ‘participant information sheet and informed consent’, the ‘study protocol’ and the ‘protocol amendments’ in searchable PDF format. Scanned documents must be converted into searchable PDF with an OCR software (Optical Character Recognition). This will help you to quickly search a words or term through the document. Click ‘Ctrl+F’ to open the search function in a Word or PDF document.
2.2. If a project is moved from one frontend account to another, messages are not moved automatically. Only if an Applicant explicitly asks for the messages to be transferred, you can do so by sending an email (per message/conversation in the back office) to the new project submitter and the whole history will appear in the new project submitter's account.
2.3. 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.