Standard Research File

Your research file must include a number of basic documents before you submit it for a primary review to an nWMO Advisory Committee. These are listed below. All submitted documents must have a version number or a date. Some of the documents only have to be submitted when applicable.

A. Correspondence

This part of your research file contains all correspondence such as letters and e-mails.

A1. Cover letter to nWMO Advisory Committee

B. Forms

This part of your research file contains all forms that are needed to submit your research and report your end of study

B1. Assessment Framework completed in Word and PDF versions (link to document).

The Assessment Framework is a general assessment and registration form. You can download the assessment framework here. The Assessment Framework must be supplied in both a Word and a PDF file.

B6. nWMO End of Study form (link to document).

For all registered nWMO research you must report the end of the study to the nWMO Advisory Committee. You can use the nWMO End of Study form for this.

If the investigation is terminated prematurely, you must provide a reason for the early termination.

C.Protocol.

C1. Research protocol.

C2. Protocol amendments (link to document)

For an amendment, you must submit a signed offer letter to the DCRF Counter where you clearly state what the changes are. All modified documents must also be submitted together with a track changes version. If the information in the Assessment Framework changes as a result of the amendment, you must also create and submit a new version of the Assessment Framework.

E. Information for research subjects

E1/2. Information leaflet and consent form research subjects

Template Subject Information

To speed up the reviewing process, you are strongly advised to use the Template Subject Information (including Subject Consent Forms) (in Dutch). This template will help investigators to write in a clear and concise manner and prevents that investigators will overlook essential parts of the information when writing the leaflet. An English translation of the template is available.

The Template Subject Information has no non-committal character. This means that this template is used as a criterion for the review by the nWMO Advisory Committee. This concerns both the structure and the wording in the information letter.

For non-study-specific components, deviations in the submitted information letter are not accepted without adequate justifications.

These are the following components:

  1. Algemene informatie;
  2. Als u niet wilt meedoen of wilt stoppen met het onderzoek;
  3. Einde van het onderzoek;
  4. Gebruik en bewaren van uw gegevens [en lichaamsmateriaal];
  5. Heeft u vragen?;
  6. Ondertekening toestemmingsformulier;
  7. Bijlagen bij deze informatie;

For the other (study-specific) components, the recommendations in the template for conciseness (focus on relevant information for the subject for the decision to participate) and appropriate language use (avoidance of medical jargon) play an important role in the review by the nWMO Advisory Committee. These are the following components:

  1. Doel van het onderzoek;
  2. Wat meedoen inhoudt;
  3. Wat wordt er van u verwacht;

The template is in line with the General Data Protection Regulation (GDPR).

E3. Promotional materials research subjects

This regards potential advertisement text or other recruitment material. All written information presented to (potential) participants in the research must be submitted to the nWMO Advisory Committee for review. This includes text to be published on a website concerning the possibility of participation in research, provided the text is related to specifically mentioned studies.

F. Questionnaires etc.

Questionnaires, patient diaries, patient cards, etc.

F1. Questionnaires

All questionnaires that must be completed by research participants must be drafted in Dutch and submitted for review. An exception is an English questionnaire usually used in the Netherlands and which has been validated.

F2. Patient diaries

Diaries that must be kept by research subjects must be drafted in Dutch and submitted for review.

J. Financial compensation

Compensation is reviewed in great detail, when assessing a non-WMO study. To make the reimbursements transparent, the form for the Reimbursement Breakdown (to be downloaded here) must be completed and sent with the application.

In addition to the maximum allowable rates, the advisory committees also assess the budget on the reasonability of the estimated time required to perform various study activities. Based on experience, the advisory committees have prepared guidance (to be downloaded here) for reasonable time spent. Any deviation from this guidance is must be explained and justified.

Procedure

  1. The applicant will mail all documents from the research file to the DCRF Counter (nwmo@dcrfonline.nl). The service desk administers the application on behalf of the DCRF, provides it with a serial number, checks it for completeness and forwards it to an nWMO Advisory Committee. Only complete research files forwarded to an nWMO Advisory Committee. When submitting a preference for a nWMO Advisory Committee can be indicated. If possible, this preference will be taken into account.
  2. The DCRF Counter creates an invoice for the assessment costs and sends it to the submitter.
  3. The nWMO Advisory Committee assesses the research file.
  4. In the event of questions, unclarity or insufficient substantiation, the nWMO Advisory Committee will inform you which parts still need attention in order for the research to be approved.
  5. The applicant informs the nWMO Advisory Committee about the changes.
  6. The advisory committee checks at the DCRF Counter whether the invoice has already been paid.
  7. The advisory committee informs the applicant about the final advice if the invoice has been paid

 

Amendments

Amendments / changes to previously assessed pharma-initiated studies that are subject to WMO must undergo a further review. The form for submitting an amendment can be downloaded here.

Minor Changes

Minor changes, such as textual changes, do not have to be submitted to the nWMO Advisory Committee.

Substantial Amendments

Substantial Amendments must be submitted to the nWMO Advisory Committee. A Substantial amendment constitutes changes in reimbursement, study design or information to the patient.

Examples of substantial amendments are:

  • updated patient information
  • offering more, fewer or different questionnaires to the patient
  • changes in the design of the research, changes in statistics, etc.
  • changes in reimbursements to participating centers
  • adjustment in the number of patients to be included.

For an amendment, you must submit a signed cover letter to the DCRF Counter where you clearly state what the changes are. All modified documents must also be submitted together with a version with track changes. If the information in the Assessment Framework changes as a result of the amendment, you must also create and submit a new version of the Assessment Framework and submit it.

In short, you must submit the following documents via nwmo@dcrfonline.nl for a substantial amendment

  • cover letter with a description of the change (s) and an overview of all documents that you are submitting
  • all changed and / or new documents (a version with track changes and a clean version)
  • if the information in the Assessment Framework changes in terms of content, you must also include a new version of the Assessment Framework.
  • Submit amendment form (link to document).

When in doubt whether an amendment should be submitted, the DCRF counter can be contacted (via nwmo@dcrfonline.nl).

Cost

Reviewing a new project costs € 2500,= (ex. BTW).

Reviewing an amendment costs € 1000,= (ex. BTW).

Upon receipt of a new submission, an invoice will be sent to the applicant. Any advice (approval or otherwise) is only given after payment of the invoice.

 

With regard to the invoicing of VAT on the costs of the nWMO procedure, the following applies:

  1. Dutch applicants will receive an invoice with 21% VAT, regardless of whether the applicant is an entrepreneur or not;
  1. Applicants in or outside the EU (entrepreneurs with VAT identification) receive an invoice without VAT. A prerequisite for this is the provision of a foreign VAT number at the time of submission, before invoicing takes place. Without this number, 21% VAT is charged (see point 3).
  1. Applicants in or outside the EU without VAT identification or not being an entrepreneur will receive an invoice with 21% VAT. The DCRF pays 21% VAT on this to the Dutch tax authorities.