B. Sponsor Identification
To add a sponsor:
- Click the ' to Add .
- Enter the Sponsor details (including Legal Representative') and when complete clickDone
- If required, you can edit or delete them at a later date.
Note:: You can also add details of the Legal Representative. When you delete a sponsor you also delete any associated Legal Representative.
Once the section is complete, the Sponsor Details are displayed in a table on this page:
For more information on the sub-sections on this page, click on the headings below to expand the section:
B.1 - Sponsor Organisation
Include the details for section B.1 Sponsor Organisation. Enter the details and click on the additional blue headings to complete these sections.
Please note that fields marked with a green asterisk are mandatory and must be filled in.
When this section is complete, click Done.
- Click in the free text field enter the name of the sponsor of the trial. Sponsor is defined in
- Enter the full name of the contact.
- Provide the full postal address to be used in case the concerned / needs to contact the sponsor by post and click the drop-down list to select the Country in which the sponsor's organisation is based.
- The contact details (phone number, fax) should be of the sponsor contact. Please include the international or applicable area codes (B.1.4, 1.5 - Conditionally mandatory - include at least one of B.1.4-B.1.6.).
- When entering the email address please be aware that functional emails are preferred to personal ones(e.g. like email@example.com or firstname.lastname@example.org) (B.1.6 - Conditionally mandatory - include at least one of B.1.4-B.1.6.).
B.2 Legal Representative
According to Article 19 of Directive 2001/20/EC, "the sponsor or a legal representative of the sponsor must be established in the Community". If the sponsor is not established in the they should appoint a legal representative established in the EEA. Like the sponsor, the legal representative can be an individual, company, institution or organisation.
Enter details in this section if required to comply with Article 19 of Directive 2001/20/EC and complete any other fields.
Please note: Only one legal representative in the EEA can act on behalf of one sponsor for the purpose of a given clinical trial (B.2).
- Enter the name of the Legal Representative (organisation or individual) in the free text field (B.2.1).
- Enter the full name of the contact in B.2.2.1 to B.2.2.3 (B.2.2.1 and B.2.2.3 ).
Tip:Use B.2.2.3 Family Name field to record a functional role, as well as a surname (e.g. Head of regulatory affairs etc.).
- In the fields B.2.3, provide the full address to use in case the concerned needs to contact the legal representative by post (B.2.3.1, B.2.3.2 - ).
- In field B.2.3.4. from the drop-down list select the Country where the Legal Representative's organisation is based (B.2.3.4 ).
- In fields B.2.4 to B.2.6, enter the contact details (phone number, fax, e-mail) of the legal representative mentioned in section B.2.2 ( Conditionally mandatory - include at least one of B.2.4-B.2.6.).
Note:Please include the international or applicable area codes.
B.3.1 and B.3.2 Status of the sponsor
A commercial sponsor is a person or organisation that takes responsibility for a trial which is part of the development programme for a marketing authorisation of a medicinal product at the time of the application.
- Click the blue bar to expand section. Click another blue heading bar to minimise the section.
- Click the drop-down list to select relevant option describing the status of the Clinical Trial's sponsor (B.3.1/B.3.2).
B.4 Source(s) of monetary or material support for the clinical trial
This section should identify the major organisations providing monetary or material support for the conduct of the trial. In many cases this will be the same as the sponsor. Where there are other organisations providing significant funding or material support these should be identified (e.g. where a funding organisation or pharmaceutical company provide support for a non-commercial trial ( including (but not limited to) funding, design, implementation, data analysis and reporting).
- Include the name of the Organisation (or individual) who is providing the finance or resources for the clinical trial in field B.4.1.
- Include the country name of the Organisation (or individual) who is providing the finance or resources for the clinical trial in field B.4.2
to add other organisations. Click to delete any entries added in error.
- Click Done when the section is completed and you return to the section overview level, where additional sponsors may be added, or existing sponsor details edited or deleted.
B.5 Contact point designated by the sponsor for further information on the trial
The contact point will be made publicly available and is the place to which members of the public should address requests for additional information about the trial.
Note: The contact point may be at the sponsor, a trial site or another organisation, and there may be one per concerned Member State or one in the EEA.
- Enter the name of the organisation.
- Provide a functional contact point rather than the name of a person (e.g. Clinical Trials Information).
- In the free text fields provide the full postal address, and using the drop-down list, select the country where the contact point is based.
- Enter the contact details (phone number, fax). These contact details are those of the further information contact.
Note:. Please include the international or applicable area codes.
- When entering the email address use a functional email instead of a personal one.
E.g.: email@example.com or firstname.lastname@example.org)