Academic trials: Additional information

What does your application contain?
The following are fictitious examples to help you determine what are the key documents for different types of trial applications.

Example 1

Trial description: What is the optimum duration of treatment with Wonderdrug tablets for the treatment of acid-related dyspepsia?

Trial design: Open label, parallel group

Test product: Wonderdrug 5 mg tablets

Dose and duration: 10 mg for two weeks

Comparator product: Wonderdrug 5 mg tablets

Dose and duration: 10 mg for four weeks

Key documents to be sent with your CTA submission:

• covering letter
• proof of payment
• receipt of confirmation of EudraCT number
• application form (and EudraCT XML file)
• clinical trial protocol with all amendments to date
• summary of product characteristics (SmPC)
• examples of the label in the national language (unless exemption 46 of SI 2004/1031 applies)
• manufacturer’s authorisation (unless exemption 37 of SI 2004/1031 applies).

Example 2

Trial description: What is the optimum dose of Wonderdrug tablets for the treatment of acid-related dyspepsia?

Trial design: Double blind

Test product: Wonderdrug 5 mg tablets (one Swedish Orange gelatine capsule containing two 5 mg tablets and one Swedish Orange gelatine capsule containing microcrystalline cellulose)

Dose and duration: 10 mg for two weeks

Comparator product: Wonderdrug 5 mg tablets (two Swedish Orange gelatine capsules each containing two 5 mg tablets

Dose and duration: 20mg for two weeks

Key documents to be sent with your CTA submission:

• covering letter
• proof of payment
• receipt of confirmation of EudraCT number
• application form (and EudraCT XML file)
• clinical trial protocol with all amendments to date
• summary of product characteristics (SmPC)
• simplified IMPD providing details on the nature of the modification and manufacture of the placebo (see mock IMPDs below for examples)
• examples of the label in the national language
• copy of the manufacturing authorisation(s) for the site(s) performing manufacture and/or assembly in order to modify the product
• TSE certificates (when applicable).

Example 3

Trial description: A randomised controlled trial to determine the efficacy of AB1234 capsules in the treatment of acid-related dyspepsia?

Trial design: Double blind

Test product: AB1234 capsules 25mg and 50mg

Dose and duration: 25mg for two weeks followed by 50mg for 2 weeks AB1234 capsules are a new product developed by Drugs-R-Us currently being used in a clinical trial in the UK sponsored by this company

Comparator product: Placebo capsules

Dose and duration: One capsule for four weeks

Key documents to be sent with your CTA submission:

• covering letter
• proof of payment
• receipt of confirmation of EudraCT number
• application form (and EudraCT XML file)
• cinical trial protocol with all amendments to date
• letter of cross referral to the CTA held by Drugs-R-Us. This should be signed by drugs-R-Us and include the EudraCT number and CTA number of the CTA to which the cross referral
• examples of the label in the national language
• copy of the manufacturing authorization(s) for the site(s) performing manufacture and assembly
• TSE certificates (when applicable)

Example 4

Trial description: A randomised controlled trial to determine the efficacy of Wonderdrug tablets in the management of hypertension

Trial design: Double blind

Test product: Wonderdrug 5mg tablets (one Swedish Orange gelatine capsule containing two 5mg tablets)

Dose and duration: 10 mg for 12 weeks

Comparator product: Placebo capsules

Dose and duration: One capsule for 12 weeks

Key documents to be sent with your CTA submission:

• covering letter
• proof of payment
• receipt of confirmation of EudraCT number
• application form (and EudraCT XML file)
• clinical trial protocol with all amendments to date
• summary of product characteristics (SmPC).The SmPC should be complemented with a summary of relevant data that support the use of the IMP in the clinical trial. This can be provided as an investigator’s brochure or may be incorporated into the protocol.
• simplified IMPD providing details on the nature of the modification and manufacture of the placebo (see mock IMPDs below for examples)
• examples of the label in the national language
• copy of the manufacturing authorisation(s) for the site(s) performing manufacture and/or assembly in order to modify the product
• TSE certificates (when applicable)

Example 5

Trial description: A randomised controlled trial to determine the efficacy of paracetamol capsules in the management of sore throat

Trial design: Double blind

Test product: Paracetamol capsules 500 mg

Dose and duration: 1000mg for two days
The paracetamol capsules are manufactured for the purposes of the trial and are not a marketed product

Comparator product: Placebo capsules

Dose and duration: Two capsules for two days

Key documents to be sent with your CTA submission:

• covering letter
• proof of payment
• receipt of confirmation of EudraCT number
• application form (and EudraCT XML file)
• clinical trial protocol with all amendments to date
• a summary of relevant data that support the use of the IMP in the clinical trial. This can be provided as an investigator’s brochure or may be incorporated into the protocol.
• simplified IMPD providing details on the manufacture of the active and placebo capsules
• examples of the label in the national language
• copy of the manufacturing authorisation(s) for the site(s) performing manufacture and/or assembly in order to modify the product
• TSE certificates (when applicable)

Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (external link)

Mock IMPDs for marketed products that have been modified for use in the trial:

Over-encapsulation of a tablet (32Kb)
Over-encapsulation of a broken tablet (44Kb)
Drug substance powder filled into capsules (37Kb)