B. Sponsor Identification

Include the details for section B.1 Sponsor Organisation. Enter details through the user interface, then click on other blue heading to open other uncompleted sections.

Click 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.

1. Click in the free text field and enter the name of the sponsor of the trial. Sponsor is defined in article 2 (e) of Directive 2001/20/EC , as "an individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial"(B.1.1 - Mandatory field).
Note: The sponsor contact should be a person who works within the company/organisation mentioned in section B.1.1 (it should not be a person working in an applicant company appointed by the sponsor (or by its legal representative) to submit the application to the National Competent Authority - applicant information is in section C) (B.1.2).
2. Enter the full name of the contact in B.1.2.1 to B.1.2.3. The middle name is not mandatory. Middle name refers to the second given name and does not refer to any part of the family name. For example, enter 'Elizabeth' for 'Ana Elizabeth' (B.1.2.2).
Tip:Use B.1.2.3 Family Name field to record a functional role, as well as a surname (e.g. Head of regulatory affairs etc.).
3. In free text fields B.1.3, provide the full postal address to be used in case the concerned NCAAcronym: National Competent Authority/ECAcronym: European Commission needs to contact the sponsor by post (B.1.3.1, B.1.3.2 - Mandatory fields).
4. In field B.1.3.4. click the drop-down list to select the Country in which the sponsor's organisation is based (B.1.3.4 - Mandatory field).
5. The contact details (phone number, fax) are those of the sponsor contact mentioned in section B.1.2. 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.).
6. When entering the email address in the free text field please be aware that functional emails are preferred to personal ones(e.g. like regulatory@corporate.com or renalcancer.ct-unit@hospital.org) (B.1.6 - Conditionally mandatory - include at least one of B.1.4-B.1.6.).

If you have followed the above steps, the sub-section should now be complete. It is recommended you now complete the following section. Click on the Blue Banner to open the next section (example below):

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 EEAAcronym: European Economic Area. Created in 1994, the EEA combines the countries of the European Union and member countries of EFTA (European Trade Association) Countries that belong to the EEA are: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom. Countries that are EEA member countries but NOT part of the European Union are: Norway, Iceland, and Liechtenstein., they should appoint a legal representative established in the EEAAcronym: European Economic Area. Created in 1994, the EEA combines the countries of the European Union and member countries of EFTA (European Trade Association) Countries that belong to the EEA are: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom. Countries that are EEA member countries but NOT part of the European Union are: Norway, Iceland, and Liechtenstein.. 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.

Click when the section is completed and you return to the section overview level. Alternatively, click on other blue heading to open other uncompleted sections.

1. Enter the name of the Legal Representative (organisation or individual) in the free text field (B.2.1 - Mandatory field).
Tip:The legal representative may be a person or an organisation.
2. 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 - Mandatory fields).
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.).
3. In free text fields B.2.3, please provide the full postal address to be used in case the concerned NCAAcronym: National Competent Authority/ECAcronym: European Commission needs to contact the legal representative by post (B.2.3.1, B.2.3.2 - Mandatory fields).
4. In field B.2.3.4. use the drop-down list to select the Country in which the Legal Representative's organisation is based (B.2.3.4 - Mandatory field).
Tip:When the drop-down in open, use the first letter of the Country to toggle through the countries with that initial letter.
5. In free text 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.

If you have followed the above steps, the sub-section should now be complete. It is recommended you now complete the following section. Click on the Blue Banner to open the next section (example below):

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.

1. Click the blue bar to expand section. Click another blue heading bar to minimise the section.
2. Click the drop-down list to select relevant option describing the status of the Clinical Trial's sponsor (B.3.1/B.3.2 - Mandatory field).
   

If you have followed the above steps, the sub-section should now be complete. It is recommended you now complete the following section. Click on the Blue Banner to open the next section (example below):

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).

1. Include the name of the Organisation (or individual) who is providing the finance or resources for the clinical trial in field B.4.1 (Mandatory field).
2. 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 (Mandatory field).
3. Click to add other organisations. Click to delete any entries added in error.
4. Click 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.
   Tip:

If you have followed the above steps, the sub-section should now be complete. It is recommended you now complete the following section. Click on the Blue Banner to open the next section (example below):.

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.

1. Enter the name of the organisation in field B.5.1 (Mandatory field).
   
2. Please provide a functional contact point rather than the name of a person (e.g. Clinical Trials Information) in field B.5.2 (Mandatory field).
3. In free text fields B.5.3, please provide the full postal address (B.5.3.1, B.5.3.2 - Mandatory fields).
4. Click the drop-down list to select the Country in which the contact point is based (B.5.3.4).
   
5. In free text fields B.5.4 to B.5.5, enter the contact details (phone number, fax)The contact details (phone number, fax,) are those of the further information contact in section B.5 (B.5.4-B.5.5 -Conditionally mandatory - include at least one of B.5.4-B.5.6.).
Note:. Please include the international or applicable area codes.
6. When entering the email address in the free text field please be aware that functional emails are preferred to personal ones (B.5.6 - Conditionally mandatory - include at least one of B.5.4-B.5.6.).
E.g.: regulatory@corporate.com or renalcancer.ct-unit@hospital.org)

If you have completed all previous sub-sections, click button.