The research file that must be submitted for primary submission contains severals parts.

A detailed explanation can be found on the CCMOCentral 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 EudraCTEuropean Union Drug Regulating Authorities Clinical Trials number

B. Forms  
    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 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/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)  
    F1:  Questionnaires  
    F2:  Patient diary  
    F3:  Patient card  
    F4:  Other

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

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