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