Paediatric Clinical Studies Methodologies and Procedures

Trial protocol and amendments

The purpose of this SOP is to describe the procedures for drafting, approval, distribution and storage of the study protocol and the related amendments.

IB and IMPD preparation

This SOP describes the purposes, contents, creation and maintenance of the Investigator’s Brochure (IB) and Investigational Medicinal Product Dossier (IMPD), respectively, for products used in clinical trials.

Final study report

This SOP describes the purposes, contents and preparation of the final clinical study report documenting the results and interpretation of the trial.

Information leaflet, consent and assent forms

The objectives of this SOP are 1) to establish roles and responsibilities for the preparation of the patient information sheet (PIS) and for obtaining of the required informed consent (IC) 2) to define the contents of the PIS and the elements of the IC form, and 3) to describe the requirements for obtaining informed consent in order to take part in a clinical trial. For an example of TEDDY SOP, please click here.

Clinical Trial Applications

This SOP is intended to provide a guidance outlining all the procedures undertaken to apply for Clinical Trial Application (CTA) in order to obtain the approval from Ethics Committees and the authorisation from Competent Authorities in the field of interventional clinical trials.

Trial Master File and Investigator Folder

This SOP describes the procedures for the definition of (a) the essential documents to be archived in the Trial Master File (TMF); (b) the essential documents to be archived in the Investigator’s Folder (IF); (c) the appropriate way to archive and store the essential documents in the TMF and in the IF.

Contracts and agreements

This SOP establishes a procedure for putting in place suitable supply contracts in the framework necessary for the implementation of clinical trials. It describes the processes for preparing, negotiating and executing binding legal agreements. It sets forth the definition of the terms and conditions associated with specific tasks outsourced or delegated.

Site selection process

The objective of this SOP is to define responsibilities, processes and deadlines for effective GCP-compliant site qualification and inclusion in clinical trials. This SOP describes the procedure for assessing site suitability for a trial prior to the initiation visit.

Study Closure

This SOP applies describes how the trial ending should be notified to the Competent Authorities and to the Ethics Committees and the archiving conditions of the trial documentations.

Site Initiation Visit

The objective of this SOP is to define responsibilities, processes and deadlines for effective GCP-compliant initiation in clinical trials. This SOP is valid for all clinical trials that are conducted in accordance with GCP. This SOP describes the procedure prior to, during and following the initiation visit in a center participating to a clinical trial.

Monitoring Visit

The objective of this SOP is to define responsibilities, processes and deadlines for effective GCP-compliant monitoring in clinical trials. This SOP is valid for all clinical trials that are conducted in accordance with GCP. It describes the procedures in planning, definition and documentation of trial-specific determinations concerning monitoring.

Close-Out Visit

The objective of this SOP is to define responsibilities, processes and deadlines for effective GCP-compliant sites’ close-out in clinical trials. This SOP is valid for all clinical trials that are conducted in accordance with GCP.

SAE Reporting

This SOP describes the procedures for the collection and reporting of serious adverse events/reactions occurring during the conduction of a clinical trial and sets out responsibilities of the concerned parties.

SAE Processing

This SOP describes the procedures for the processing of serious adverse events (SAEs) received during the conduction of clinical trials and sets out responsibilities of the concerned parties.

SAE Archiving

This SOP describes the procedures for the archiving of serious adverse events (SAEs) received during the conduction of clinical trials and sets out responsibilities of the concerned parties.

SAE Reconciliation

This SOP describes the procedures for reconciling serious adverse events (SAEs) reported during the conduct of a clinical trial in the Study Database with the SAEs recorded in the Safety Database, identifying the workflow activities by role. The reconciliation is performed to assure that serious adverse events are accurately captured, interpreted, and consistently reported to regulatory authorities.

Set-up of Clinical Trials Supply and Drug Management Activities

This SOP describes the procedures for the IMP management during the conduction of a clinical trial and sets out responsibilities of the concerned parties. The SOP can be applied to each clinical trial and the related the investigational medicinal products (IMPs) independently from their marketing authorization status in any Member State or Third Country involved in the trial, whether or not IMPs are used under the conditions of marketing authorization.

Preparation, review, approval and distribution of SOPs

This SOP outlines the process for preparing, reviewing and approving the SOPs to be used in GCP-compliant clinical trials. Moreover this SOP describes the processes for the amendments, distribution and archiving of the SOPs, and illustrates training program for the staff involved