Clinical Trial and Innovation Area
Description
Proposed new clinical trials
- PA 31 Proposed clinical trials and observational studies, (see regulations – clinical trials regulation)
- Forms for the submission of a new clinical trial or observational study
- Annex 13-Modules DGRT n. 414 of 10/02/2016 (B1, B2, B3, B4, B5, B6, B7, B12)
- PA 71 Management of non-profit pharmacological clinical trials
- Attachment1 Single centre opening declaration form
- Attachment2 Log of signatures of staff authorised to conduct the clinical trial
- Attachment3 Monitoring visit log
- Attachment4 Log of experimental drug loading and unloading
- Attachment5 First Patient Enrolment Form
- Attachment6 Progress Status Form
- Attachment7 Study Closure Form
- Attachment8 Register of Patients Enrolled
- Attachment9 Protocol Deviation Register
- Attachment10 Experimental Drug Destruction Report
- PA 72 Monitoring the economic agreement of for-profit clinical trials
- Attachment1 Economic Agreement Monitoring Form for Profit-making Clinical Trials (MESP)
- Attachment2 Economic agreement form
Pharmaceutical product management for clinical trials
- PA 25 Management of pharmaceutical products in clinical trials
- Attachment1 Experimental drug withdrawal form
- Attachment2 Drug delivery form to investigator
- Attachment3 Experimental drug return form
- Attachment4 Investigational drug re-labelling form
