The research file that must be submitted for primary submission contains severals parts.
A detailed explanation can be found on the CCMO (Central Committee on Research involving Human Subjects) website, see also the document Standard Research file with comments.
Standard Research File
A. Letters
A1: Cover letter to review committee and competent authority
A2: Authorisation letter from the sponsor, if the applicant is not the sponsor
A3: Confirmation EudraCT (European Union Drug Regulating Authorities Clinical Trials) number
B. Forms
B1: ABR form (General 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 CCMO 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/GMO (Genetically 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 SUSARs (Suspected Unexpected Serious Adverse Reactions) not yet mentioned in IB (including summary and assessment)
D2: IMPD (Investigational 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)
F1: Questionnaires
F2: Patient diary
F3: Patient card
F4: Other
G. Insurance information
G1: Insurance certificate for WMO (Medical Research Involving Human Subjects Act) research with human subject insurance
G2: Proof of coverage of investigator or sponsor, for example liability insurance
H. Résumés
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