Show:
Definitions
Pub Team Roles & Responsibilities
Forms Forms Forms
Manuscript Requirements
Authorship & Miscellaneous
100
Individuals or agencies who contributed materially to the manuscript, but whose contributions do not justify authorship; includes those who contribute materials, financial support, technical help (e.g., data collection and analysis, statistical assistance), or substantive help in editing or writing the paper or in preparing and formatting the publication for submission.
What is an Acknowledged Contributor?
100
If publication projects not managed by GSMP will be outsourced to a medical communications agency or freelance writer, these are the contact people in GSMP for Merck publication development training materials for the outsourced personnel.
Who are Carolyn Hustad and Pamela Jameson?
100
This document allows for an author who provided significant contributions but did not fulfill all of the ICMJE criteria and is unresponsive to multiple requests for the Acknowledgment Form, to be moved from the byline to the acknowledgment section
What is the Author Agreement form?
100
All authors are required to list this directly in the manuscript. Journal forms that collect this information should be retained.
What are their potential conflicts of interest relevant to the manuscript?
100
Once your manuscript has been published, you need to return to the OSTIC website and add this information to the record for that cleared publication.
What is the citation information? Note: You do NOT need to upload the FINAL manuscript versions.
200
This is inclusion of someone as an author who did not fulfill International Committee of Medical Journal Editors (ICMJE) authorship criteria.
What is Guest Authorship?
200
Although these groups will manage their own outsourced manuscripts, GSMP will track the publication milestones and archive final publications in Datavision when appropriate.
What are the Center for Observational and Real-World Evidence (CORE) groups?
200
These forms do not need to be collected/dated before submission as long as those signing the forms have communicated their approval before the manuscript is published. It is recommended, however, that these forms be collected before submission to ensure that all forms are properly completed and archived before the manuscript is published. The completed form needs to be retained.
What are the Author Contribution Form and Acknowledged Contributor Form?
200
This detail should appear preferably at the end of the abstract in the manuscript for primary and secondary clinical manuscripts or as directed in the journal's instructions to authors.
What is the clinical trial registry number (NCT#) or other local country clinical trial registry number?
200
An OSTIC reviewer can take any one of the following actions when assessing whether a publication can be publically disclosed.
What are Approval with no comments; Discretionary comments; Holds?
300
This is usually the Clinical Director, but occasionally may be another person in charge of the study (such as Outcomes Research staff for cost-effectiveness analysis, etc.). If a SAC or PC exists, the SAC/PC co-chairs may take over certain roles.
Who is the Monitor?
300
If no PubTeam exists, the Publication Manager will bring subsidiary publication plans to this group for discussion and prioritization.
What is the appropriate Product Development Team/Clinical Sub-Team?
300
Relevant conflicts of interest outside the submitted work should be reported for this specific time frame.
What is 36 months prior to submission?
300
If the journal will allow posting the redacted protocol in Supplemental Materials, but stipulates this to do so, we would reply to the journal that we will not post the redacted protocol.
What is charging a fee?
300
In accordance with Corporate Policies 26, 43, and 50 for secure transfer of documents, the writer or Pub Manager, under the direction of the Clinical Director, will disseminate this package to the authors via secure method.
What is the distribution of the clinical Study Results Data Package?
400
This cross-functional team responsible for oversight of all aspects of the clinical development of an investigational compound, including project management, conducting clinical studies, filing for marketing approval with regulatory agencies, dissemination of scientific information about the compound, scaling up for manufacturing of the product to be available when regulatory approval is obtained, and marketing the approved product.
What is the Product Development Team (PDT)?
400
The responsibilities of the Publication team include: • Develop the scientific publication plan • Ensure publications from all areas are prioritized according to the publication strategy for the franchise/therapeutic area and agree on preliminary timelines • Evaluate intended content and rationale for proposed publications (why it is needed, what new information it will contribute to the literature) • Discuss audience and possible scientific congresses or journals for data dissemination • Allocate writing resources if needed (internal or outsourced) • Manage progress of publications • Track all global publications related to a product • Review science and study data to brainstorm and identify new analyses for future publications stemming from clinical study data (secondary analyses). Three of these were added as New responsibilities of the Publication Team during the recent revision.
What are • Manage progress of GSMP-led publications • Track all global publications related to a product • Review science and study data to brainstorm and identify new analyses for future publications stemming from clinical study data (secondary analyses)
400
Use and completion of these author forms documents compliance with good publication practice regarding author involvement in the writing process and certifies author understanding of and compliance with Merck standards and should be used for all in-scope manuscripts (not for abstracts, posters/presentations, or other media).
What are the Author Agreement, Author Contribution Form, and Acknowledged Contribution Form?
400
This summary must be submitted to clinicaltrials.gov or other required clinical trial database before the corresponding manuscript can be submitted to the journal for a registered trial for an approved product. Requests for exceptions should be submitted to the Registration and Results (R2) Executive Committee.
What is the posting of a results synopsis?
400
The following communications, including this 1 new addition to the list, do not require OSTIC clearance: Merck Investigator-Initiated Studies Program (MISP) investigator-initiated study (IIS) publications when there are no Merck co-authors; materials that are intended solely for promotion of marketed products; educational materials, datasets to share with collaborators/external scientific researchers, publicly accessible regulatory documents; materials for use at advisory boards, investigator meetings, consultant meetings, or Food and Drug Administration (FDA) public hearings; and press releases.
What are datasets to share with collaborators/external scientific researchers?
500
This department includes Discovery Chemistry, therapeutically-aligned Discovery groups, Pharmacology, Early Stage Development, and Human Genetics and Pharmacogenetics.
What is Early Development and Discovery Sciences department (EDDS)?
500
Core PubTeam members customarily include: • Publication Manager • GSMP/Agency Medical Writer(s) • Clinical Research • Clinical Pharmacology • Epidemiology • Global Director of Scientific Affairs (GDSA) • Global Health Outcomes • Product Development Team (PDT) Chair/Clinical Development Leader However, two members were recently added to this list.
Who are Agency Medical Writer(s) & Product Development Team (PDT) Chair/Clinical Development Leader?
500
Before writing begins or as soon thereafter as possible, authors must provide confirmation that they agree to the 4 conditions outlined in the Author Agreement. Two of the 4 criteria were added in the recent revision. 1. Fulfill ICMJE authorship criteria (listed above) 2. Agree to disclose actual contributions to the manuscript and potential financial or other conflicts of interest. 3. Agree to keep confidential any proprietary information and materials shared with them during the drafting of the manuscript. 4. Agree to adhere to the timelines for the publication process
What are numbers 2 and 3?
500
These are subject to the same rules for manuscript-related author documentation and disclosure of potential conflicts and writing/editorial support as other scientific/medical manuscripts.
What are Review articles?
500
One of the following ICMJE recommendations below, which state that authorship credit should be based on satisfaction of all of the following criteria, was added in the recent revision of the PDP 5.4.1: 1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND 2. Drafting the work or revising it critically for important intellectual content; AND 3. Final approval of the version to be published; AND 4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
What is (number 4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved?