What must I submit for Part A of the application?Read moreAbout What must I submit for Part A of the application?
Documents belonging to Part A of the application form should preferably be submitted via the 'berichtenbox' or via a digital information carrier (CD-ROM or USB stick). A folder structure and naming must be maintained as shown in Table 1, where:
- All documents must be submitted in PDF/A format.
- All articles belonging to the application must be submitted in a separate folder called "Artikelen". This folder with scientific articles will not be made public.
- Other public documents, including protocols, guidelines or procedures must be placed in a folder called “Openbaar”.
- All documents that are claimed to be confidential must be clearly marked as confidential and placed in folder called "Vertrouwelijk”.
- Please use ZIP-files in case of large number of appendices.
The following documents must be supplied as hard copy or via the 'berichtenbox':
- Signed cover letter
- General (personal) information
- Consent form
- Optional: mandate Environmental Safety Officer (ESOenvironmental safety officer )
In those cases where a signature of the legal entity is requested, a pen-drawn signature on a printed copy of the document is required. Forms that are submitted via the 'berichtenbox' do not have to be signed. The ‘eHerkenning’ of the 'berichtenbox' procedure is sufficient.
Extract NHR and/or mandate ESO
The signing of the legal entity is always verified and therefore the data in the Dutch Business Register (NHR) of your organization must always be up-to-date. On behalf of the legal entity a person must sign who is registered as an authorized signatory in the NHR. On behalf of legal entities a person may also sign who is mandated. The mandate containing the sign authority must be attached. If the 'berichtenbox' is used, the correct authorization is arranged via the ‘eHerkenning’.
Tabel 1. Documents and structure for digital submission
|Application form Part A||PDF/A|
|All public guidelines, protocols and documents (no articles) as separate files||PDF/A|
|Signed cover letter||PDF/A|
|General (personal) information||PDF/A|
|Mandate Environmental Safety Officer (ESOenvironmental safety officer )||PDF/A|
|All (scientific) articles as separate files|
|All appendices as separate files that are claimed by the applicant as confidential||PDF/A|
What must I submit for Part B of the application?Read moreAbout What must I submit for Part B of the application?
The ABR formGeneral Assessment and Registration form belonging to Part B of the application form must be submitted via the web portal ToetsingOnline, http://www.toetsingonline.nl/. You may include certain data which can be uploaded from the EudraCTEuropean Union Drug Regulating Authorities Clinical Trials form. On the CCMOCentral Committee on Research involving Human Subjects website you will find an example of the ABR form and explanatory notes.
Once you have a final version of the ABR form you must send in a signed version, together with your research file, on two CD-ROMs in PDF/A format together with a signed cover letter on paper to the Gene Therapy Office. The CCMO prefers digital submission of your application. It is also possible to send the application in duplicate on paper.
The Ministry of VWSMinistry of Health, Welfare and Sport requires digital submission, which means that the cover letter should be on paper but all remaining documents should be submitted in PDF/A format on a single CD-ROM, coded according to the standard research file (more information is available at http://www.ccmo.nl/, ´standard research file´).
Standard Research File
A1: Cover letter to review committee and competent authority
A2: Authorisation letter from the sponsor, if the applicant is not the sponsor
A3: Confirmation EudraCTEuropean Union Drug Regulating Authorities Clinical Trials number
B1: ABR formGeneral Assessment and Registration form including a summary: online at http://www.toetsingonline.nl and on paper (signed and dated)
B2: Local addendum to ABR form (not applicable when CCMOCentral Committee on Research involving Human Subjects acts as ethics committee)
B3: EudraCT Application Form: on paper (signed and dated) and in XML format at http://www.toetsingonline.nl
B4: Part A of the application form for the assessment of clinical research involving gene therapeutics (Gene therapy/GMOGenetically Modified Organism form)
C. Protocol and amendments
C1: Research protocol
C2: Protocol amendments (if applicable) in chronological order
D. Product information
D1: Investigator’s brochure (publication date: < 1 year old) and overview of SUSARsSuspected Unexpected Serious Adverse Reactions not yet mentioned in IB (including summary and assessment)
D2: IMPDInvestigational Medicinal Product Dossier (or SPC, if applicable), incl. list of relevant research with the medicinal product under investigation
D3: Examples of labels in Dutch
D4: Applicable statements/licences
D5: Hospital pharmacist product details (if applicable)
D6: Additional product details, e.g. for gene therapy: nucleotide sequence of the vector
E. Information for research subjects
E1: Research subject/representative information leaflet
E2: Consent form(s)
E3: Any advertising texts or other enrolment materials
E4: Other informational materials
F. Questionnaires, patient diaries, patient cards, etc. (if applicable)
F2: Patient diary
F3: Patient card
G. Insurance information
G1: Insurance certificate for WMOMedical Research Involving Human Subjects Act research with human subject insurance
G2: Proof of coverage of investigator or sponsor, for example liability insurance
H1: Independent doctor(s) or other independent expert(s) résumé(s)
H2: Coordinating investigator résumé (if applicable, only for multicentre research)
I. Information per participating centre in the Netherlands
I1: List of participating centres and principal investigators
I2: Research Declaration from the head of the department (or equivalent) per centre
I3: Résumé for the principal investigator per centre
I4: Other information per participating centre
J. Additional information regarding financial compensation (if not mentioned on the ABR form)
J1: For research subjects
J2: For investigators and centres
K: Other relevant documentation
K1: Copy of reviews by other institutions (e.g. grant giving body or scientific committees or recommendations by regulatory authorities)
K2: Overview list of authorised foreign institutions that the protocol has been submitted to, along with a copy of reviews by foreign MRECs/ECs or competent authorities (for example VHP)
K3: Signed clinical trial agreement between the sponsor or funder and the investigator and/or institution
K4: Scientific publications (regarding previous/comparable research provided by the submitting party)
K5: Data Safety Monitoring Board (composition, charter)
K6: Other documents (e.g. letters for general practitioners/treating medical consultants, recommendation of the radiation committee
Figure 1. Diagram document flow for official submission to the Gene Therapy Office.