SOP：临床试验从欧盟临床试验指令向欧盟临床试验法规的过渡

SOP: Transition of OngoingClinical Trialsfrom the EUClinical Trial Directive to theEU Clinical Trial Regulation SOP: Transition of Ongoing Clinical Trials from the EUClinical Trial Directive to the EU Clinical Trial Regulation Purpose To describe the process for assessing ongoing clinical trials and submitting regulatoryapplications to transition trials from the EU Clinical Trials Directive 2001/20/EC (CTD) to theEU Clinical Trials Regulation 536/2014 (CTR) using the Clinical Trials Information System(CTIS). The CTD established the principles for conducting clinical trials of medicinal products inmember states of the European Union (EU)/European Economic Area (EEA). The CTD hasbeen replaced by the Clinical Trials Regulation that became applicable on Jan. 31, 2022,though certain legacy trials may remain under the Directive until Jan. 30, 2025. Scope This standard operating procedure (SOP) applies to all ongoing interventional clinical trialsauthorized under the CTD with at least one active site in the EU/EEA as of Jan. 30, 2025, aswell as those trials on EudraCT requiring an amendment subject to approval by the memberstates (e.g., adding sites in a new member state) before Jan. 30, 2025. Responsibilities •The Clinical Operations department assesses trials and determines which needs tobe transitioned. •The Regulatory Affairs department is responsible for preparing and submitting theapplications to transition trials to the CTR. See your organization’s EMA CTA Submission SOP for additional roles and responsibilities. SOP: Transition of Ongoing Clinical Trials from the EUClinical Trial Directive to the EU Clinical Trial Regulation Procedure Assess trials for transition: Assess your organization’s ongoing trials on EudraCT. Trials mustbe transitioned if: •The trial will have at least one active site in an EU/EEA member state on orafter Jan. 30, 2025, where a site is considered active until the Last PatientLast Visit (LPLV) or if trial-specific interventions are ongoing.NOTE: Trials that have ended locally in all EU/EEA member states in line withthe CTD do not need to be transitioned, even if the global end of the trial hasyet to be reached.•The trial requires an amendment subject to approval by the member statesbefore Jan. 30, 2025, such as adding sites in a new member state. For trials meeting initial criteria, determine if all Part I and II documents havebeen harmonized across member states or consolidated into a single versionreflecting country-specific differences. 2 Categorize trials into two groups: •Expedited: Single-country or multinational trials where all documents areharmonized, and the protocol is either harmonized or consolidated acrossmember states. The transition of trials eligible for the expedited procedure isexpected to be completed within 22 days. •Not expedited: Multinational trials where the documents are not yetharmonized or consolidated across member states. Based on guidance,unless there are substantial differences (e.g., the trial objectives),it is recommended to consolidate documents such as the protocol,Investigational Medicinal Product Dossier (IMPD), and InvestigatorBrochure (IB) across member states instead of submitting an amendment toharmonize these. However, the appropriate approach should be discussed with the memberstate’s regulatory authorities. While a consolidated version may beacceptable in cases of alignment, sufficient time should be allowed toaddress any concerns or requests for modifications during the assessmentprocess. If it is not possible to submit consolidated documents, a recentsurvey suggests planning for at least 100 days to harmonize the documentsof a multinational trial to be conservative. SOP: Transition of Ongoing Clinical Trials from the EUClinical Trial Directive to the EU Clinical Trial Regulation Procedure Prepare expedited transition applications: For expedited transitions: •Author, review, and approve a cover letter for the transition application peryour organization’s EMA CTA Submission SOP •Prepare a statement on compliance with GDPR on compliance with personaldata protection laws in line with the EMA template Statement of Compliancewith Regulation (EU) 2016/679 (GDPR)•In CTIS, enter the required structured data for Parts I and II•Upload previously approved CTD documents-Part I: Protocol, IB, IMPD, Good Manufacturing Process (GMP) docs,non-Investigational Medicinal Product (IMP) info-Part II: Informed Consent Forms (ICFs), subject info sheets•Provide additional previously approved CTD documents if applicable•Create placeholder documents for those not yet approved under CTD•Generate the transition application Complete a quality review per your organization’s EMA CTA Submission SOP. Submit an expedited transition application byOct. 16, 2024, perEMA guidelines. If the Oct. 16 deadline to submit the transition application is missed, theprocesses may take longer than 22 days. Additionally, the EMA has an end-of-year “clock sto