Standard Research File

When submitting for the first time to a non-WMO Advisory Committee, your research file must consist of a number of basic documents. These are listed below. All submitted documents must be marked with a version and/or date. Some documents only need to be submitted if applicable.

A. Correspondence

This part of your research file contains all correspondence, such as letters and emails.

A1. Cover Letter

B. Forms

This part of your research file contains all the forms required for registering and deregistering your research. You fill out these forms in the Research Portal and then you can download them as PDFs. After submission, you will also receive a PDF by email.

B1a. ABR Form

B1b. Progress Status Form

This form is used to report the start, end, and any premature termination of your research.

B1e. Other Notification Form

B1f. Final Results Form

This form is used to submit the final results of your research.

B1g. Request for Extension of Decision Form

B1h. Objection to Disclosure Form

B1j. Objection to Submission Decision Form

B2. Local Addendum

This form contains additional questions for the ABR form. You need to fill out the form and attach it as a PDF in the Research Portal.

C.Protocol.

C1. Research protocol.

C2. Protocol amendments

For an amendment, you must submit a signed cover letter in which you clearly indicate what the changes are. Additionally, all modified documents, along with a version showing track changes, must be submitted. If the information in the ABR form or due to the amendment changes substantively, you must also make these adjustments in the ABR form.

E. Information for research subjects

E1/2. Information leaflet and consent form research subjects

Template Subject Information

Template Subject Information (Dutch)

To speed up the reviewing process, you are strongly advised to use the Template Subject Information (including Subject Consent Forms). 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.

M2a. Results and Publications

Once the research is completed, you are requested to submit a summary of the results and/or any scientific publications within one year after the end of the study (worldwide). You need to answer the questions in the Final Results form and you can also add the following documents:

M2a. Summary of results for disclosure

M2b. Research report

M2c. Publications

Procedure

  1. The applicant submits all information and documents in the Research Portal. The DCRF desk checks it for completeness and forwards it to an nWMO advisory committee. Only complete research dossiers are submitted to an nWMO Advisory Committee. When submitting, a preference for an nWMO Advisory Committee can be indicated. If possible, this preference will be taken into account.
  2. The DCRF desk creates an invoice for the assessment costs and sends it to the submitter.
  3. The nWMO advisory committee assesses the research dossier.
  4. In case of questions, ambiguities, or insufficient substantiation, the nWMO advisory committee will indicate which parts still need attention in order to meet the admissibility requirements.
  5. The applicant informs the nWMO Advisory Committee about the adjustments via the Research Portal.
  6. The advisory committee checks with the DCRF desk whether the invoice has been paid.
  7. The advisory committee informs the applicant of the final advice once 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 in the Research Portal clearly indicating the changes. All revised documents, along with a version with track changes, must also be submitted. If the information in the ABR form changes substantively due to the amendment, you must also adjust the questions in the ABR form.

In summary, for an amendment, you must submit the following documents:

  • Cover letter describing the change(s) and an overview of all documents you are submitting
  • All revised and/or new documents (a version with track changes and a clean version)
  • If the information in the ABR form changes substantively, you must also adjust the questions in the ABR form.

If in doubt whether an amendment needs to be submitted, you can contact the DCRF desk (via nwmo@dcrfonline.nl).

Cost

Reviewing a new project costs € 3250,= (ex. BTW).

Reviewing an amendment costs € 1300,= (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.