Scope of Policy
This document applies to Entities, functions, and personnel, including contractors, consultants, service providers, and partners which perform or support interventional clinical trials/clinical studies/clinical investigations on behalf of, as Baxalta sponsor or as cosponsor of Baxalta using the following Baxalta investigational materials:
- Investigational and/or marketed drug/biologic products / medicinal products
- Investigational and/or marketed medical devices
This document does not apply to Sponsor-Investigator studies as defined by ICH E6 and ISO 14155. When a Baxalta function supports clinical trials/clinical studies/clinical investigations as a clinical service provider, e.g. as a Contract Research Organization, all activities performed by Baxalta shall follow this procedure.
Any exemption needs approval of the Chief Medical Officer, Global Clinical Quality and Global Legal.
The purpose of this document is to describe the Baxalta Quality Management System (QMS) requirements and process for Baxalta-sponsored interventional clinical trials/clinical studies/clinical investigations.
Responsibility and Authority
|Management with Executive Responsibility|
- Implementing and enforcing the requirements described in this document
- Ensuring that this document is cascaded down to the appropriate functions
- Conducting the clinical trial
- Immediate direction of administration, dispensation and use of investigational product
- Role of sponsor for all clinical trials that are initiated, managed, and/or financed by Baxalta and are under full control of a Baxalta function
1.1 Regulatory Requirements
1.1.1 Clinical trials shall be conducted in accordance with applicable regulations, standards, local laws, and generally accepted regulatory and ethical guidance of the country(ies) where the study is conducted.
1.1.2 Clinical Trials shall follow Good Clinical Practice. Good Clinical Practices includes those standards established by the International Conference on Harmonization (ICH) and the International Organization for Standardization (ISO) for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial subjects are protected, as reflected in the Informed Consent.
1.1.3 Clinical trials shall be conducted according to the provisions of the applicable version of the “Declaration of Helsinki”.
1.1.4 Standards issued by ICH (drugs and biologics) and ISO (medical devices) shall be followed as a minimum rule unless superseded by country-specific laws, or regulations. Baxalta standards may be more stringent than local regulations and should be followed.
1.1.5 Clinical trials conducted in the US or clinical trials to be submitted to US regulators shall comply with all the applicable sections of the Code of Federal Regulations.
1.1.6 Clinical trials conducted in the European Union (EU) shall comply with all the applicable EU regulations and guidance.
1.1.7 Applicable local laws and regulations for other countries (for example, Japanese GCP requirements, Japanese GCP for Medical Devices, Medical Device Directive (MDD) for European device studies) shall be followed.
1.2 Process Requirements
1.2.1 All Baxalta divisions, regions and functions conducting or sponsoring clinical trials shall adopt the minimal requirements outlined in this document.
1.2.2 Procedures shall be established and followed to assure compliance with laws, regulations, and guidelines of the country where the:
- clinical trial is conducted
- results of the clinical trial will be used for regulatory submission and/or
- investigational product is manufactured and/or released
1.2.3 All responsibilities of a sponsor as outlined in the applicable laws and regulations shall be followed. Procedures shall be established and followed to describe how the sponsor responsibilities shall be fulfilled.
1.2.4 For any clinical trial that prospectively assigns human participants or groups of humans to one or more research related interventions to evaluate the effects of health outcomes, the clinical trial shall be disclosed. Non-interventional studies are outside the scope of this procedure, but must be conducted in compliance with applicable local regulatory/ethical and data protection standards and/or good epidemiological practice. If available, global standards should apply.
1.3 Key Elements of a Clinical Trial
1.3.1 All clinical trials shall be conducted according to a written protocol in accordance with applicable legal and regulatory requirements.
220.127.116.11 In order to ensure clinical protocols are aligned with Baxalta’s quality standards and applicable regulatory requirements, each division/facility conducting clinical trials shall ensure clinical protocols are developed with input from, and review by, the responsible organizations with appropriate expertise in the following areas: Medical/Clinical, Regulatory, Pharmacovigilance/Drug Safety (trials involving drugs or biologics), Product Surveillance (for device studies), Statistics, and Data Management. Clinical Quality will be consulted as applicable.
18.104.22.168 At a minimum, the protocol shall be approved in writing by the following personnel:
- Sponsor’s medical officer (e.g. the Medical Director) responsible for the clinical trial application
- Representative of the Regulatory function
- Representative of Global Drug Safety/Product Surveillance
- Member of the global Statistics organization supporting clinical product development
22.214.171.124 All required elements of the clinical trial application for approval to commence a clinical trial (e.g. protocol, investigator’s brochure, and specified documents) must be submitted to the appropriate regulatory or competent authorities for review, acceptance and or approval as required by applicable country regulations and guidelines, where the clinical trial will be conducted.
1.3.2 All clinical trials shall be performed by individuals qualified by training and experience. Clinical investigators must not be debarred/disqualified or otherwise restricted by a regulatory authority from participating in clinical research.
1.3.3 A clinical trial shall not be started without prior written approval by a properly constituted, accredited Independent Ethics Committee / Institutional Review Board with legal responsibility for the site(s) where the trial is to be conducted.
1.3.4 Except as permitted under emergency-use regulations, prior to participation in a clinical trial, written informed consent shall be obtained from all participating clinical trial subjects (or the subject’s legally acceptable representative). Note: Informed consent shall be documented in writing, signed, and personally dated by the subject or the subject’s legally acceptable representative, and by the person who conducted the informed consent discussion (i.e. the investigator, or a person designated by the investigator), and an impartial witness as applicable under local requirements.
1.3.5 All proprietary information shared with the clinical trial site/investigator must be protected under a confidentiality agreement, and no subjects shall be enrolled at a given clinical study site without completion of a clinical trial agreement between the sponsor and the clinical trial site/investigator.
1.3.6 Clinical trials shall be conducted in a manner that ensures compliance with Baxalta’s privacy principles, local/regional privacy protection requirements and contractual agreements.
1.3.7 Investigators shall be instructed to report Adverse Events as described in the protocol. The sponsor shall report adverse events/adverse drug reactions to appropriate authorities worldwide according to international and local regulations.
1.3.8 Once the clinical trial is completed or terminated, a final report shall be prepared according to regulations and, at a minimum, approved in writing by the same functions that approved the clinical trial protocol.
1.3.9 Completion or termination of the clinical trial shall be reported to local regulatory authorities and to the Independent Ethics Committee/Institutional Review Board according to local laws/regulations.
1.3.10 Records of clinical trials shall be maintained according to Baxalta requirements and applicable governmental regulations.
1.4 Investigational Product / Test Article
1.4.1 All product used in a clinical trial shall be manufactured and released according to applicable regulations of the country of manufacture and the country(ies) where the clinical trial will be conducted.
1.4.2 As required by competent authorities, an Investigator’s Brochure shall be developed, updated and provided to participating clinical investigators.
1.4.3 All investigational product used in a clinical trial shall be appropriately labeled according to applicable regulatory requirements.
1.4.4 Requirements for the shipping, disposition, storage and destruction of the investigational product(s) shall be followed according to applicable regulations.
1.4.5 These requirements shall be established in written procedures.
1.5.1 In the event an external clinical service provider, e.g. a Contract Research Organization (CRO), is contracted by the sponsor to assume/perform one or more of the sponsor’s clinical trial-related duties and/or functions, used in the conduct of a clinical trial, the function using the external clinical service provider shall assure that the provider is evaluated and acceptable according to Baxalta requirements prior to signing the contract.
1.5.2 Transfer of clinical trial-related responsibilities from the sponsor to a clinical service provider shall be documented in writing.
1.6 Quality Assurance and Quality Control
1.6.1 Policies and procedures shall be in place to ensure that clinical trials are performed in accordance with GCP and regulatory requirements.
1.6.2 Plans and controls to ensure oversight and monitoring of data integrity and subject safety shall be implemented throughout the clinical trial.
1.7 Data Transparency
1.7.1 Baxalta adheres to the principles of responsible data sharing laid out by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) and complies with requirements from the International Committee of Medical Journal Editors (ICMJE), and with the positions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on disclosure of clinical study information and results. Baxalta has implemented a procedure that covers the process for publication of redacted/anonymized clinical documents as per EMA Policies 0070 and 0043 Policy (EMA/110196/2006) and the PhRMA/EFPIA Principles.
1.7.2 Baxalta demands transparency in clinical study design and results with the aim of empowering patients and healthcare professionals to make informed decisions about treatment. Upon initiation of a clinical trial, protocol information is posted on publicly accessible online registries. After completion or termination of a clinical trial, results are posted, regardless of the outcome, according to laws and regulations, on publicly accessible online registers including www.clinicaltrials.gov, www.clinicaltrialsregister.eu, www.encepp.eu, and country-specific/national trial registries, as applicable. The results of Baxalta clinical trials are published in peer-reviewed medical journals in order to disseminate clinical study results to the scientific community.
1.7.3 Baxalta’s Clinical Trials Disclosure website provides redacted/anonymized clinical study report synopses as well as factual lay summaries (upon implementation of EU Clinical Trial Regulation 536/2014) on clinical trial results for medicines and indications approved in the US and EU since January 1, 2015. Patient-level data will be released for clinical trials initiated after July 1, 2015, in which patients provided informed consent to use clinical study data for legitimate academic and non-commercial research.
1.7.4 Baxalta is committed to protect patients’ privacy by safeguarding their personal data and restricting the use of data from clinical trials so that the scope of patients’ informed consent is respected. Personal data and certain confidential information contained in clinical study synopses and summaries is redacted/anonymized prior to posting on publicly accessible sites.
- Global Policy on Interactions with the Medical Community and Government Officials for Baxalta
- ICH E6, Good Clinical Practice
- ISO14155, Clinical investigation of medical devices for human subjects - Good clinical practice
- European Medicines Agency policy on publication of clinical data for medicinal products for human use (EMA/240810/2013), Policy 0070
- European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use) (EMA/110196/2006), Policy 0043
- European Clinical Trial Regulation (No. 536/2014) on clinical trials on medicinal products for human use repealing Directive 2001/20/EC
- PhRMA and EFPIA Principles for Responsible Clinical Data Sharing