Table 1.

Recommendations from the ENCePP Code of Conduct, the ISPE Guidelines for Good Pharmacoepidemiology Practice (GPP), and the ADVANCE Code of Conduct for postauthorisation studies.

Topics	ENCePP Code of Conduct	ISPE Guidelines for Good Pharmacoepidemiology Practice (GPP)	ADVANCE Code of Conduct
Objective	To support scientific independence and transparency throughout the research process; to strengthen the confidence in the integrity and value of the research.	To help ensure the quality and integrity of research; to facilitate transparency and ethical integrity.	To support effective collaborations and clear governance for the conduct of collaborative postauthorisation vaccine studies.
Scope	Noninterventional postauthorisation studies	All types of pharmacoepidemiological (PE) research.	Postmarketing vaccine benefit‐risk monitoring activities.
Guiding principles	Scientific independence and transparency	Sound PE research, framework for conducting and evaluating PE studies, appropriate utilisation of technical resources, transparency, ethical integrity	Best science, strengthening public health, transparency
Participants	Protocol developed by individuals with appropriate scientific background and experience, but after protocol finalisation, no person with commercial, financial, institutional, or personal interest in any outcome of the study should be part of any study activity that could influence results or interpretation.	Personnel should have education, training or experience necessary to perform the assigned functions.	All study team members to be qualified and to act in accordance with values of honesty, accuracy, and objectivity.
Rights and obligations	Primary lead investigator (PLI) ultimately responsible for study protocol, study conduct, and analysis, interpretation, and publication of results; study funder to be kept informed of study progress (eg, progress with recruitment but not interim results).	Organisation(s) or individuals conducting and sponsoring the research to be fully responsible; roles and responsibilities to be described. Responsibility for scientific integrity to be shared by collaborating institutions. Right for the study sponsor to inspect the contractor's facilities and perform audit.	No undue influence of any financial, commercial, institutional, or personal interest in a particular outcome of the study. Clear and transparent roles and responsibilities.
Declaration of interests	Direct and indirect commercial, financial, institutional, or personal interests to be declared by core team members and made public.	Potential conflicts of interest, financial and nonfinancial, to be disclosed in manuscripts.	Documented autonomy of study team members for making decisions in their organisation. Regulatory updated declarations of interest to be disclosed. Study protocol to include sections on funding, affiliations, and potential conflicts of interest. Actual or potential conflicts of interest to be addressed at the planning phase and their management to be included in research contract.
Research contract	PLI to be without financial, commercial or institutional interest that could influence study in any particular direction. Full compliance with ENCePP CoC to be referred to in contract. List of aspects to be addressed.	If shared responsibility, research contact to delineate roles and responsibilities of study sponsor and contractor.	Should not lead investigators to act against the Helsinki declaration or applicable legislation. Clarity and transparency. ADVANCE CoC to be referred to. List of elements to be included.
Study protocol	To be developed with appropriate scientific background and experience. ENCePP Checklist for study protocols to be consulted. Process for protocol agreement on design options between PLI and study funder to be agreed beforehand. Protocol to be published in EU PAS Register before start of study. Amendments to be documented.	To be drafted as one of first steps in research project and to be amended or updated throughout the course of study. Detailed description of content of protocol, to be included in case no regulatory guidance exists. Significant deviations to be documented in writing. Registration of protocol in public site is welcomed without the option to retract the protocol.	To be drafted as one of first steps in research project and developed with persons of relevant expertise. Process for decision making to be agreed beforehand. Contribution of each party to study design, protocol writing, and study work programme to be described. Independent scientific review by external experts. To be amended as needed and changes to be identifiable. To be registered in publicly available database before data collection.
Study registration	Study to be registered in EU PAS Register by PLI and entry to be regularly updated	Registration of PE research in public site (EU PAS Register, clintrial.gov) is welcomed.	Study to be registered in publicly available database before start of data collection or extraction.
Study conduct	Once the protocol is finalised, no person with commercial, financial, or institutional interest in any outcome of the study to be part of any study activity that could influence the results or interpretation thereof in any particular direction, except if technical expertise needed. Post hoc analyses to be done only to generate further hypotheses. Members of steering group must be without direct or indirect commercial, financial, or institutional interests. Persons with interests may be appointed as invited specialists without involvement in decision making. Composition of steering group to be made publicly available.	PI to be responsible for overall content of the research. Decisions to terminate the study to be based on good scientific and ethical reasons and documented in writing. Description of procedures for data collection, management, and verification to be followed. All data management and statistical analysis programmes used in analyses to be documented and archived. Analysis to be directed towards unbiased estimation of the epidemiological parameter of interest; use of confidence intervals and sensitivity analyses.	Sensitivity analyses to be planned. Additional analyses based on study results to be presented as such and used only to generate further hypotheses. Plan to handle missing and noninterpretable data to be developed.
Study results	Review of results by independent experts and PLI to address recommended changes and justify why changes are not accepted. PLI to respond to requests by third parties. Study report to follow ISPE GPP, STROBE, RECORD, and GVP.	Description of format and content of study report to be included.	Interpretation of study results to be the responsibility of the study team. Important safety concerns to be documented and evaluated. Deviations from study protocol to be clearly documented. STROBE statement to be followed. Draught report to undergo independent scientific review.
Dissemination and publication	Dissemination strategy to be predefined Summary of results in the EU PAS Register within 3 months. PLI has the right to prepare publication irrespective of data ownership; study funder entitled to view the final results and interpretations and provide comments. ICMJE guidelines to be followed.	Ethical obligation to disseminate findings of potential scientific or public health importance. Procedures for communications of the intent, conduct, results, and interpretation of epidemiology results to be predetermined. Recommendations for format of results to be reported. ICMJE guidelines to be followed.	PI and study team to be allowed by contract to publish independently from study funder. All study results to be made available and intermediate results to be presented or published based on procedure agreed in advance; significant results of public health importance to be published rapidly with statement of their preliminary nature; regulatory and public health authorities to be rapidly informed of study results. Source of funding, affiliation, and potential conflicts of interests to be presented. Study report or summary of results to be included in publicly accessible database. ICMJE guideline to be followed.
Data ownership and sharing.	Rights of ownership of data and results to be included in research contract. Rules for access to raw data, processed data, and results to be specified in protocol and research contract. Verification of published results to be allowed Data transformation steps to be described on request. Analytical data set to be shared based on justification of public health interest and compliance to the Code of Conduct or audit by authority.		Open and collaborative approach to be adopted. Data to be shared only after study report finalised. Data sharing to be based on a written request justifying public health interest. Decision to share data to be taken by study team Analysis of shared data to follow ADVANCE CoC.
Protection of human subjects, confidentiality	Confidential information to be defined in advance and specified in research contract or separate document.	Approval by IRB or IEC to be obtained with exceptions in some countries. Confidentiality to be maintained; personal identifiers to be removed or protected.	Protocol to describe data protection and incentives for study subjects. Applicable legislation to be followed.

Abbreviations: CoC: Code of Conduct; GVP, EU Good Pharmacovigilance Practices; ICMJE, International Committee of Medical Journal Editors; IRB, institutional review board; IEC, independent ethics committee; PI, principal investigator (GPP); PLI, primary lead investigator (ENCePP CoC).