G. Clinical Trial Sites/Investigators in the Member State

Complete the InvestigatorA doctor or a person following a profession agreed in the Member State for investigations because of the scientific background and the experience in patient care it requires The investigator is responsible for the conduct of a Clinical Trial at a trial site If a trial is conducted by a team of individuals at a trial site, the investigator is the leader responsible for the team and may be called the principal investigator. Sites in this Member State only. At least one (the principal of a single centre or coordinator of a multiple centre trial) should be added.

In order to enter Investigator details, click Add Investigator and the G.1 and G.2 Investigator screen appears.

1. First, click the drop-down list, then select the investigator's role from the available options.
2. In G.1.1/G.2.1 free text field, insert the Investigator's given name, which is also known as first name or forename.
3. In G.1.2/G.2.2 free text field, click in the free text field and include the investigator's middle name. 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' (up to 100 characters).
4. In G.1.3/G.2.3, click in the free text field and include the investigator's family name, which is also known as the surname.
5. In G.1.4/G.2.4, click in the free text field and include the investigator's professional qualifications (up to 50 characters).
6. In G.1.5/G.2.5 (Institution Name), click in the free text field and include the full name of the Institution or Organisation that the investigator works for.
7. In G.1.5/G.2.5 (Institution Department Name), click in the free text field and include the full name of the department of the above named Institution or Organisation that the investigator works in.
8. In G.1.5.1/G.2.5.1, click in the free text field and include the building name and/or number and street name.
9. In G.1.5.2/G.2.5.2, click in the free text field and include the town or city where the investigator is based.
10. In G.1.5.3/G.2.5.3, click in the free text field and include the address' post code (where applicable).
11. In G.1.5.3/G.2.5.3, select the relevant country from drop-down list.
12. In G.1.6/G.2.6, click in the free text field and include the contact details (phone number, fax, e-mail) of the investigator mentioned in section G.1.1/G.2.1-G.1.3/G.2.3).
13. In G.1.7/G.2.7, click in the free text field and include the contact details (phone number, fax, e-mail) of the investigator mentioned in section G.1.1/G.2.1-G.1.3/G.2.3).
14. In G.1.8/G.2.8, click in the free text field and include the contact details (phone number, fax, e-mail) of the investigator mentioned in section G.1.1/G.2.1-G.1.3/G.2.3).

When all the fields are completed (in any order), click and you return to the G. Clinical Trial Sites/Investigators in the Member State screen.

Only central facilities who supply services for at least this Member State should be included. The facility may be in this Member State, another Member State or a Third CountryA third country is a country outside of the European Union/European Economic Area..

In order to enter Investigator details, click Add Central Technical Facility and the G.3. Central Technical Facilities Details screen appears.

1. In G.3.1 Name of Organisation, click in the free text field and include the full name of the Institution or Organisation that the Central Technical Facility (CTFAcronym: Central Technical Facility) is a part of.
2. In G.3.2 Central technical facility organisation department, click in the free text field and include the full name of the specific department within the Central Technical Facility.
3. Enter the full name of the contact in G.3.3.1 to G.3.3.3.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' (G.3.3.2).
   Tip: Use G.3.3.3 Family Name field to record a functional role, as well as a surname (e.g. Head of regulatory affairs etc.).
4. In free text fields G.3.4, please provide the full postal address of the above identified Central Technical Facility.
5. In field G.3.4.4 click the drop-down list to select the Country in which the Central Technical Facility is based.
6. The contact details (phone number, fax) are those of the contact person mentioned in section G.3.3. Please include the international or applicable area codes (G.3.5, G.3.6).
7. 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) (G.3.7).
8. In field G.3.8.1, select 'Yes' if the CTF will provide routine clinical pathology testing.
9. In field G.3.8.2, select 'Yes' if the CTFAcronym: Central Technical Facility will provide clinical chemistry analysis or testing.
10. In field G.3.8.3, select 'Yes' if the CTFAcronym: Central Technical Facility will provide Clinical haematology analysis or testing.
11. In field G.3.8.4, select 'Yes' if the CTFAcronym: Central Technical Facility will provide Clinical microbiology analysis or testing.
12. In field G.3.8.5, select 'Yes' if the CTFAcronym: Central Technical Facility will provide histopathology analysis or testing.
13. In field G.3.8.6, select 'Yes' if the CTFAcronym: Central Technical Facility will provide serology/ endocrinology analysis or testing.
14. In field G.3.8.7, select 'Yes' if the CTFAcronym: Central Technical Facility will provide analytical chemistry.
15. In field G.3.8.8, select 'Yes' if the CTFAcronym: Central Technical Facility will provide ECGAcronym: Electrocardiogram analysis/ review.
16. In field G.3.8.9, select 'Yes' if the CTFAcronym: Central Technical Facility will provide medical image analysis/ review - X-ray, MRI, ultrasound, etc.
17. In field G.3.8.10, select 'Yes' if the CTFAcronym: Central Technical Facility will provide Primary/ surrogate endpoint test.
18. In field G.3.8.11, select 'Yes' if the services provided by a central technical facility are not covered in the above options. Then complete the free text field below.
19. In field G.3.8.11.1, click in the free text field and include the services provided by a CTFAcronym: Central Technical Facility (up to 100 characters).

When all the fields are completed (in any order), click and you return to the G. Clinical Trial Sites/Investigators in the Member State screen.

Now complete sections G.4-G.5, as outlined below. Click to expand the below headings for further step-by-step instructions.

Include details of any Clinical Investigator Network involved in the Clinical Trial.

In order to enter details of any Clinical Investigator Network involved in the Clinical Trial, click Add Trial Network and the G.3. Central Technical Facilities Details screen appears.

1. In free text fields G.4.1, include the name of the organisation of any Clinical Investigator Network involved in the Clinical Trial, if applicable.
   Tip: Additional networks may be added in the G. Clinical Trial Sites/Investigators in the Member State screen.
2. Enter the full name of the contact in G.4.2.1 to G.4.2.3.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' (G.4.2.2).
   Tip: Use G.4.2.3 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 G.4.3.1-G.4.3.3, please provide the full postal address of the above identified Central Technical Facility. 
4. In field G.4.3.4,additionally, click the drop-down list to select the relevant country from drop-down list.
5. In field G.4.4-4.6, the contact details (phone number, fax, e-mail) are those of the network contact mentioned in section G.4.2. Please include the international or applicable area codes and email address.
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) (G.4.6).
7. In field G.4.7, click in the free text field and include the activities performed by the trial network pertaining to the CTAAcronym: Clinical Trial Application (up to 2000 characters).

When all the fields are completed (in any order), click and you return to the G. Clinical Trial Sites/Investigators in the Member State screen.

Only central CROAcronym: A contract research organization, also called a clinical research organization is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services (for both drugs and medical devices). facilities supplying services for at least this Member State should be entered (not e.g. individual field-based CRAs). The facility may be in this Member State, another Member State or a Third Country

In order to enter details of any Sponsor's Subcontractor Facility involved in the Clinical Trial, click Add Sponsor's Subcontractor Facilities and the 'G.5.Organisations to whom the sponsor has transferred trial related duties and functions' screen appears.

1. In field G.5.1.1, click in the free text field and include the full name of the Institution or Organisation to which the Sponsor has transferred Clinical Trial related duties and functions.
2. In field G.5.1.2, click in the free text field and include the full name of the department of the above named Institution or Organisation to which the Sponsor has transferred Clinical Trial related duties and functions.
3. In field G.5.1.3.1, click in the free text field and include the contact person's given name, which is also known as first name or forename.
4. In field G.5.1.3.2, click in the free text field and include the contact person's middle name. This refers to the second given name and does not refer to any part of the family name. For example, enter 'Elizabeth' for 'Ana Elizabeth'.
   Note: The middle name is not mandatory.
5.  In field G.5.1.3.3, click in the free text field and include the contact person's family name, which is also known as Surname.
   Tip: Use this field to record a functional role, as well as the family name.
6. In free text fields G.5.1.4.1-5.1.4.3, please provide the full postal address of the above identified Sponsor's Subcontractor Facility.
7. In field G.5.1.4.4 click the drop-down list to select the Country in which the identified Sponsor's Subcontractor Facility is based.
8. The contact details (phone number, fax) are those of the subcontractor contact mentioned in section G.5.1.3. Please include the international or applicable area codes (G.5.1.5, G.5.1.6).
9. 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) (G.5.1.7).
10. In field G.5.1.8, select 'Yes' if the sponsor will delegate all tasks of sponsor.
11. In field G.5.1.9, select 'Yes' if the vendor will undertake monitoring duties.
12. In field G.5.1.10, select 'Yes' if the vendor will undertake regulatory duties (e.g. preparation of applications to CA and Ethics Committee).
13. In field G.5.1.11, select 'Yes' if the vendor will undertake investigator recruitment/selection duties.
14. In field G.5.1.12, select 'Yes' if the vendor will undertake treatment randomisation duties or duties include the setup, maintenance and operation of automated Interactive Response systems, like IVRS (voice), IWRS (Internet/world wide web based) or hybrid ones.
15. In field G.5.1.13, select 'Yes' if the vendor will undertake Data Management duties.
16. In field G.5.1.14, select 'Yes' if the vendor will undertake electronic data capture (EDCAcronym = Electronic Data Capture) duties.
17. In field G.5.1.15, select 'Yes' if the vendor will undertake drug safety duties that involve SUSARAcronym: Suspected Unexpected Serious Adverse Reaction(s). reporting.
18. In field G.5.1.16, select 'Yes' if the vendor will perform Quality Assurance auditing.
19. In field G.5.1.17, select 'Yes' if the vendor will undertake statistical analysis.
20. In field G.5.1.18, select 'Yes' if the vendor will undertake Medical writing duties.
21. In field G.5.1.19, select 'Yes' if the vendor will undertake other duties subcontracted not mentioned above.
22. In field G.5.1.19.1, click in the free text field and include other duties performed by the subcontractor on behalf of the sponsor, if not detailed in the above options (up to 100 characters).
If the above steps are completed, including mandatory fields, the subsection is complete.

When all the fields are completed (in any order), click and you return to the G. Clinical Trial Sites/Investigators in the Member State screen.