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