Medical Research

Document Purpose 8.3.1 Updates of the Investigator's Brochure (IB) To document that the investigator must be informed promptly of the relevant information as it becomes available 8.3.2 Revisions
- Protocol / amendment (s) and CRF
- Informed Consent Form
- Any other written information provided to subjects
- Alerts for subject recruitment (if used) To document revisions of these documents that came into effect during the study 8.3.3 Approval / favorable opinion dated and documented IRB / IEC with regard to:
- Amendment (s) of the Protocol
- A review of:
- Informed consent form
- Any other written information to be provided to subjects
- Alerts for subject recruitment (if used)
- Other documents that have received approval / favorable opinion
- Continuing review of the study (if required) To document that '(the) amendment (s) and / or revisions have been submitted to the IRB / IEC and have received approval / favorable opinion. To identify the version and date of the document (s) (s) 8.3.4 A UTHORIZATION / Approval / Notification of regulatory authorities, if required, to:
- Amendment (s) of the protocol and other documents To document compliance with applicable regulatory requirements 8.3.5 Curriculum Vitae for new (i) the investigator (s) and / or co-investigator (s) See 8.2.10 8.3.6 Updates normal values ​​/ ranges for procedures / medical examinations / instrumental / laboratory included in the protocol To document normal values ​​and ranges that were reviewed during the study (see 8.2.11) 8.3.7 Updates to procedures / medical examinations / instrumental / laboratory:
- Certification or
- Accreditation or
- Quality control and / or external quality assessments or
- Other validation (if required) To document that tests remain adequate throughout the course of the (if required) study (see 8.2.12) 8.3.8 Documentation submission (s) Product (s) in the studio and materials related to the study (See 8.2.15) 8.3.9 Certificate (s) of analysis for new batches of products in study (See 8.2.16) 8.3.10 Reports of monitoring visits To document the visits at the center and the observations dell'addetto monitoring 8.3.11 Other relevant items in addition to the reports of visits
- Letters
- Notes of meetings
- Notes of telephone calls To document any agreements or significant discussions regarding the administrative aspects of the study, protocol violations, the conduct of the study, the reporting of Adverse Events 8.3.12 Informed consent forms signed To document that consent has been obtained in accordance with the Good Clinical Practice and with the protocol and dated prior to the subject's participation in the study. Also to document direct access permission (see 8.2.3) 8.3.13 Original Documents To document the existence of the subject and to validate the integrity of the study data collected. To collect the original documents relating to the study, the clinical treatments and medical history 8.3.14 Cards collecting data (CRF) completed, signed, dated To document that the investigator or an authorized member of his staff, with-(copy) (original) 8.3.15 Documentation of corrections in CRFs To document all changes / additions or corrections made on the CRF after initial data recording 8.3.16 Notification of the investigator to the sponsor of serious adverse events and related reports Notification of the investigator to the sponsor of serious adverse events and related reports in accordance with paragraph 4.11 8.3.17 Notification of the sponsor and / or investigator, where applicable, to the regulatory authorities and the IRB / IEC of adverse drug reactions and other serious or unexpected safety information Notification of the sponsor and / or investigator, where applicable, to regulatory authorities and IRB / IEC adverse drug reactions serious and unexpected in accordance with the points 5.17 and 4.11.1 and other safety information in accordance with section 16.5 .2 8.3.18 Notification of the sponsor to investigators of safety information Notification of the sponsor to investigators of safety information in accordance with section 5.16.2 8.3.19 Interim or annual reports to IRB / IEC and the Authority Interim or annual reports provided to IRB / IEC in accordance with section 4.10 and to the authorities in accordance with section 5.17.3 8.3.20 Register persons valutat To document identification of subjects who entered the pre-selection study List of codes to identify subjects To document that the investigator / institution keeps a confidential list of names of all persons to whom has been assigned a number for the study at enrollment. It allows the investigator / institution to reveal the identity of each subject Register of subjects enrolled To document the enlistment from a chronological point of view, using the numbering given to subjects Quantitative management of (i) product (s) in the studio at the headquarters experimental To document that the product (s) (i) has been used in the study according to the protocol Sheet of signatures To document signatures and initials of all Registration of any samples of organic nature (fluid / tissue) stored To document the place of preservation and identification of samples if the tests are to be repeated