Obstetrics and Periodontal Therapy (opt) Study Manual of Operations Version 1 March 3, 2003 Brief Table of Contents



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IV.Policies and Reporting



PART IV.
POLICIES AND REPORTING

IV.1. Good Clinical Practice
IV.1.1. General Principles.
The integrity and credibility – that is, the quality – of the trial is determined by the commitment the investigative team makes to protecting the rights and the safety of subjects and to generating quality data. This manual describes the steps necessary to assure that personnel are trained and qualified to complete their assigned tasks, and that progress is monitored in these areas throughout the trial.
We adhere to the International Conference on Harmonization’s general principles of Good Clinical Practice. These principles dictate, first and foremost, that we have weighed and continue to weigh the anticipated benefits versus the foreseeable risks to subjects. Participants are fully informed of these risks before they are enrolled. We closely monitor subjects for obstetrical and periodontal adverse events throughout the trial and make available to participants any necessary rescue or emergency care. The study's leadership continually review the medical and dental literature to determine if new findings substantially affect the study's rationale or justification, or if new or previously unforeseen risks must be conveyed to participants. The study's leadership also shares any such findings with the DSMB and the NIDCR program official in a timely manner so informed decisions can be made about continuing the trial.
Study treatment will be rendered under the direction of a qualified and licensed dentist or obstetrician. Only qualified and trained personnel will collect clinical data or process and analyze laboratory samples.
The study protocol and consent processes have been reviewed and approved by the Institutional Review Boards (IRBs) of the respective Enrollment Sites and the University of Minnesota. While the responsibility for maintaining human subjects approval rests with the Enrollment Site PI, the study leadership, during the Steering Committee’s semiannual meeting or conferences, monitors the approval status of each site to ensure that no subject is enrolled unless the trial has current IRB approval at that site.
All study personnel who have contact with subjects or data will be required to complete a course on human subjects protection. The Enrollment Site PI and the directors of the coordinating centers and laboratories are responsible for ensuring that their personnel have completed an approved training program. This training may be obtained through the Site or center’s parent institution, or by completing an approved online course such as the one offered through the National Cancer Institute (http://cme.nci.nih.gov/).
The study leadership also conducts periodic reviews of study procedures to ensure subjects' confidentiality and privacy. Each Enrollment Site PI also regularly reviews with his/her team the protocol for handling clinic and study records. Each PI develops a system – probably unique to each Site, depending on the physical layout of the facility and the Site's customary distribution of responsibilities among study personnel – to ensure that randomization codes remain accessible only to the Study Coordinator (and to the consulting periodontist as needed); that a subject’s clinic and study records are returned to secure and private locations in a timely manner; and that study-related data cannot be linked to personal identifiers.
IV.1.2. Monitoring
(See also Section III.10, "Data and Safety Monitoring Activities")
While its is impossible to ensure the integrity and quality of a trial without a trained investigative team, it is also imperative to institute a regular and rigorous monitoring program to assure that the team adheres to the study protocol and protects the rights and privacy of subjects. The Enrollment Site PI is the person primarily responsible for assuring this compliance. S/he regularly reviews study progress with team members and conducts periodic audits to ensure that informed consent has been obtained and documented. The PI does not, however, have access to assigned study treatments so the study's blind is not jeopardized. The PI reviews his/her team’s operations and progress to ensure that study records are up to date, complete, and kept in a secure place accessible only to appropriate study personnel.
The Data Coordinating Center's Statistical Study Manager also conducts periodic on-site audits of each enrollment site. During these visits, the Study Manager reviews a random sample of case report forms and source documents to ensure that the information on the forms is complete and consistent with the source documents, that missing visits are recorded, and that the disposition of subjects who complete or exit the study is recorded. The Enrollment Site PI ensures that the Study Manager has access to all study documents and pertinent obstetrical and dental records. Finally, the Study Manager reviews the reporting, documentation and follow-up of serious adverse events to assure that these events were handled according to procedures described in this manual. On-site audits are conducted at each site once a year during the course of the trial, and again following completion of the trial.
The Study Manager prepares a report to present to the DSMB and to the Steering Committee. The study leadership reviews and discusses the results of these audits during its semiannual meetings. Recurring or frequent protocol violations, omissions or errors by an Enrollment Site are discussed with the PI at that site. The PI, with the guidance of the study leadership, develops a remedial training program and oversight mechanism for his/her investigative team. Subsequent and repeated violations may warrant discontinuation of enrollment at that site.
IV.2. Reports
Any aspect of a study that is not monitored and periodically reported will deteriorate and the resulting data will be of poor quality, perhaps unusable. But if such reporting is used in a punitive manner, the resulting mistrust impedes problem-solving. Thus, an essential function of the Data Coordinating Center (DCC) will be to prepare the following reports:
• Monthly quality control reports to the Sites' Study Coordinators, and

• Twice-yearly reports to the Steering Committee and DSMB,


and to provide this information in a constructive manner oriented to identifying and solving problems quickly.
The monthly quality control reports to the Sites' Study Coordinators will describe, for each individual Site:
• Recruitment: numbers enrolled, numbers randomized, reasons for not randomizing enrollees.

• Visits scheduled and visits attended.

• Withdrawals from the study or losses to follow-up.

• Protocol adherence: improper consenting or violations of eligibility criteria or confidentiality.

• Error and missing-data rates on forms and timeliness of response to error corrections.

• Timeliness of weekly forms packages and birth-data collection.


These reports will be sent to the Site Study Coordinators at mid-month and will be the subject of monthly conference calls including all Sites' Study Coordinators and the Statistical Study Manager from the DCC. These conference calls will be arranged by the DCC.
The twice-yearly reports to the Steering Committee and DSMB will include all of the items reported monthly (see the previous paragraph), as well as summaries of subject characteristics, trends, and problem areas.
DSMB reports are described in detail in Section III.10.

IV.3. MOP Maintenance
Producing and maintaining the Manual of Procedures (MOP) is the responsibility of the Data Coordinating Center (DCC).
The MOP will be distributed to all Sites in loose-leaf binders, which allow sections to be replaced by revisions. The DCC will send to each Site as many copies as the Site requests, and will send further current copies on request. Each page of the MOP will be numbered, dated, and contain a version number to ease changes or additions.
When any changes are made in the OPT study's procedures, forms, or other things documented in the MOP, the DCC will revise the MOP expeditiously to reflect those changes. Such revisions will involve these steps:
• DCC personnel write a draft revision with contributions as appropriate from affected study personnel.

• Comments are solicited from affected personnel for a specified period.

• DCC personnel produce a penultimate version for approval by affected personnel.

• Upon approval, the revised manual sections are sent from the DCC to all Sites, with instructions as to which pages (numbers, version numbers, and dates) are to be replaced by the new sections.


IV.4. Miscellaneous Policies
IV.4.1. Conflict of Interest
Investigators or study personnel with real or potential conflicts of interest will be required to describe the nature of the conflict(s) in writing for review by the Enrollment Site PI. The PI will act on this information at his/her own discretion. In the event that an Enrollment Site PI has a conflict of interest, s/he will be required to describe the nature of the conflict in writing for review by the Study Chair, who will bring the issue before the Steering Committee for discussion. If the putative conflict is judged to be real and will likely jeopardize the conduct of the trial at that site, the PI (or Steering Committee) will ask the person to divest him/herself from such conflict or will relieve the individual of his/her study-related duties.
Data Safety and Monitoring Board members are required to verify, in writing, that they do not have a conflict of interest in serving on this oversight board. The NIDCR program official maintains this documentation.
IV.4.2. Dental Care to Participants
All subjects will receive non-surgical periodontal therapy in accordance with community standards of care. Test subjects will receive this treatment between 13 and 20 weeks of pregnancy. Control subjects will receive this care shortly after delivery. Rescue treatment, including mechanical and perhaps antibacterial therapy, will be available to all subjects who experience progressive periodontitis during the course of the trial.
Essential dental care, defined as treatment of carious or abscessed teeth, will be provided to all study subjects between 13 and 20 weeks of pregnancy. This care will consist primarily of removing carious tooth structure, placing temporary or permanent (composite or alloy) restorations, and providing endodontic treatment for abscessed teeth. Anterior teeth extracted by study dentists during the course of the trial will be replaced using transitional partial dentures. Permanent partial dentures, crowns (caps) or bridges, or restorations that are indicated for esthetic reasons alone will not be placed as part of this study. Subjects will be financially responsible for any dental care they receive outside of this study. Exceptions will be made to this policy if emergency, after hours care was required to treat a condition or pathosis that was judged, by reasonable standards, to be related to or an adverse event of the study.
IV.4.3. Insurance
Subjects, regardless of whether they have some form of public or private dental insurance, will not be billed for any study-related dental or periodontal treatment. As such, no program income will be generated during the course of this trial.
IV.4.4. Disclosure of Results with the Study
Other than the Study Coordinator, Site personnel will not have access to the randomization codes and subject log. The Study Coordinator will inform select individuals of a subject’s group assignment in special circumstances, in particular, the consulting periodontist in the event that a subject experiences generalized progressive periodontitis. Obviously, the treatment hygienist will know if a subject is assigned to the test group, but she will not have access to the subject's patient ID (PID). The Study Coordinator will access the subject log at the time a subject is enrolled or in the event of certain adverse events. The randomization codes will remain inaccessible to other study personnel until the trial is completed and all data have been forwarded to the DCC. The original study forms will be forwarded regularly to the DCC for entry into the study databases. Copies of the forms should remain in the subject’s casebook at the Site; the casebooks should remain locked in a secure and private site when not in use. The PI and Statistical Study Manager can gain access to the case books as part of their quality assurance exercises, but in no instance should these or other individuals have simultaneous access to a subject’s case books and the randomization code.
See Section IV.4.5 (Publications and Presentations) for a description of how summary statistics and results are requested from the DCC.
IV.4.5. Publications and Presentations
(Adapted with permission from the University of Minnesota "Oral Infections and Vascular Risk in Seven Countries Policy" study.)
Study investigators have the right and responsibility to communicate their findings to the scientific community and to the public. To minimize errors in data reporting, all data and text considered for publication in scholarly journals or presentation at scientific meetings must be submitted to the Steering Committee and Data and Safety Monitoring Board (DSMB) for prior review and approval. The Data Coordinating Center also shall review the data summaries to verify that they are accurate and consistent with data presented in other study documents and papers.
IV.4.5.1. Objectives
The objectives of this policy are:
1. To assure and expedite orderly and timely presentations to the scientific community of all pertinent data resulting from the study.
2. To assure scientifically accurate presentation and papers from investigators.
3. To assure that all investigators, particularly those of junior rank, have the opportunity to participate and be recognized in the study-wide presentations and publications.
4. To assure that press releases, interviews, presentations, and publications of study materials are accurate and do not compromise the scientific integrity of this collaborative trial.
5. To establish procedures that allow the Steering Committee and DSMB to review publications and presentations in a timely manner.
6. To maintain a complete up-to-date list of presentations and publications, and to distribute such lists to all investigators.
7. To clarify and ensure proper acknowledgement of NIH and non-NIH support of studies and publications.
IV.4.5.2. Definitions
Main papers and presentations are those reporting results dealing with the main hypotheses of the randomized controlled trial (i.e., primary and secondary end points, the design of the trial) as well as papers and presentations using the common data set.
Other papers and presentations are those not encompassed by the above category; they relate to work done in ancillary studies (studies not relating to the original main hypothesis) or by a single center.
IV.4.5.3. Proposal and Approval Process
The following procedures will be used to propose papers for publication:
1. To initiate the process that might lead to a presentation at a scientific meeting, or writing a paper for publication, all study investigators and professional staff are invited to submit written proposals for abstracts or for papers to the Steering Committee.
2. The proposal should clearly state the research question or hypothesis and include a brief background statement to clarify the purpose and importance of the research question. If approved to go forward, a writing group will be formed, as specified below.
IV.4.5.4. Selection of Writing Group Members and Writing Group Chairperson
Writing group members are selected as follows:
1. As soon as the concept for an abstract or paper has been identified and approved by the Steering Committee, the Chairman will communicate with all centers requesting nominees of qualified and interested investigators to participate as members of a writing group for that paper, as well as seeking the rationale for each nominee for the writing group. The request for nominees will include a specific date (deadline) for submission of nominations.
2. The Steering Committee will select from the submitted list of nominees the membership of the writing group for each paper and will also identify a lead person for that writing group, so that the group may expeditiously proceed with the task. In general, the proposer of the idea for the paper abstract will be the lead person.
3. It is the responsibility of the lead person to communicate with other writing group members, to develop a detailed manuscript outline, to identify data and analysis needed from the Data Coordinating Center, and to assume leadership in writing the manuscript. In general, the lead person will be the first author of the paper.
4. The Steering Committee is charged with the task of periodic systematic reviews of the work of all writing groups, aiding and encouraging members as appropriate, revising their membership or reconstituting the group membership, with written notification, when indicated. It is the intent that selection of writing committee members be equitable and fair to all groups and individuals participating in this collaborative program, including encouragement of participation by younger professional colleagues, with due regard paid to exceptional efforts of groups or individuals.
IV.4.5.5. Preparation and Submission of Papers
The following steps should be followed in the preparation of manuscripts. The lead person of each writing group should:
1. Contact members of the writing group and review its specific charge;
2. Draft prototype tables that are appropriate and needed to write the manuscript;
3. Be aware that the Data Coordinating Center will process all requests for data and analysis according to the overall priorities of the parent study;
4. In consultation with writing group members, submit prototype tables or data analysis requests to the Data Coordinating Center and the Chairman of the Steering Committee;
5. Ensure that members of the writing group participate in the writing and review of the paper. Input from every member of the writing group should be encouraged.
6. Approve the final version of the paper before its submission to the Steering Committee. All members of the writing group should see the final draft before its submission to the Steering Committee and DSMB;
7. Ensure that, in general, membership of writing groups is restricted to study investigators and professional staff. Others not formally associated with the study may become involved in some aspects of data analysis and publication if sponsored by a principal investigator, and approved by the Steering Committee.
If, in the judgment of the Steering Committee, a writing group is not working well or if there is an unjustifiable delay in writing the assigned paper, the Steering Committee may reappoint a leader or the entire group to expedite progress.
IV.4.5.6. Authorship and Clearance
For main papers and presentations, names of members of the writing group shall be listed as authors in the masthead, with the addition of the phrase "for the OPT Study Group." The lead person of the writing group, with the concurrence of other members of the group, should determine the order of authorship. The lead person may choose to add investigators to the authorship who are not on the writing group. A major criterion for order of authorship shall be the effort and contribution made by the members of the writing group in preparation of the manuscript. The Steering Committee will resolve disagreement about the order of authors that cannot be resolved by the lead person of the writing group.
1. The phrase "for the OPT Study Group" added after the names of the authors in the masthead is optional in papers reporting local data, or ancillary studies using local data.
2. Requests for reprints of other papers reporting data from a limited number of subjects should be directed to the lead author (or the author's designee).
3. The Steering Committee shall have the final authority to review and approve all papers including those based on ancillary studies, sub-studies, or local center data. The DSMB shall review and approve the primary trial abstract(s) and manuscript(s) to determine that the results are fairly presented and the conclusions appropriate (per NIDCR's Data and Safety Monitoring Guidelines, draft dated 15 November 2002).
4. The chairman of the Steering Committee will be required to submit a final draft of each paper to the Data Coordinating Center for final check on accuracy of the data. This will be done simultaneously as the paper is submitted to the Steering Committee and DSMB for review.
5. The Data Coordinating Center staff will be requested to submit their review within a reasonable time limit (generally not to exceed one month) and provide feedback to the chairman of the Steering Committee as soon as possible.
6. Since not all circumstances that might cause disagreement among investigators on the merit of a given paper can be foreseen, these disagreements should be resolved by the Steering Committee.
7. Every effort should be made to accommodate the expression of differing interpretations and alternate analyses within the body of each manuscript, so that all points of view are represented to the satisfaction of every participant.
IV.4.5.7. Preparation and Submission of Abstracts for National and International Meetings
The Administrative Center will maintain a current list of all relevant meetings and their deadlines for submission of abstracts.
1. All abstracts of main, other, and ancillary study papers must be approved by the Steering Committee before they are submitted to any national or international organizations. The primary trial abstract(s) should also be approved by the DSMB to determine that the results are fairly presented and the conclusions appropriate. Abstracts submitted to the Steering Committee for review should be accompanied, if appropriate, by copies of tables and graphs to support the conclusions of the abstract. It is understood that some descriptive abstracts may not require data submission or the data may be contained in the abstract. In order for the Data Coordinating Center to meet the request of investigators for data analysis for abstracts, and allow sufficient time for writing the abstract, the writing groups, or individuals submitting the abstract, should be selective and timely in their data requests. That is, only tables that relate to the major topics of the abstract should be requested. Detailed tabulations dealing with special topics should be reserved for the preparation of the text for meeting presentations or for the manuscript for publications. Generally, five or six tables should be sufficient. On rare occasions, examination of these five or six tables may necessitate one or two additional tables. In these situations, the Data Coordinating Center should meet these additional requests in a timely basis, if at all possible.

2. Any member of the Study Group may prepare an abstract on a subject appropriate to the investigation. Such an abstract may be based on the topic already assigned to a writing group, in which case the person preparing the abstract should be a member of that writing group or, the abstract may be on an entirely new topic, in which case it could originate from any investigator member of the Study Group.


3. If an abstract is submitted for a topic for which there is no writing group, and if the topic and the abstract are approved, a writing group will be activated. Regardless of the nature of the abstract, it must be approved by a writing group if that abstract deals with the topic assigned to that group and the Steering Committee.
4. In general, no abstract shall be submitted to any national or international organization for consideration prior to approval of the Steering Committee. If the Steering Committee or DSMB disapproves of an abstract already submitted, the author(s) will be required to withdraw that abstract immediately. The time limit for review and approval of an abstract by the Steering Committee should not exceed 2-3 weeks after the Steering Committee chairman has received the abstract.
5. If an abstract is prepared on a topic for which a writing group has not yet been selected, it is the responsibility of the Steering Committee to select a writing group as soon as the content of the abstract is approved. The Data Coordinating Center should have a representative on this writing group, as in most writing groups, to expedite communication with the Data Coordinating Center and facilitate timely analysis of data and preparation of art work and slides for presentation.
6. The selection of the person who will present the material in the abstract at the respective national or international meeting will be at the discretion of the respective writing group (if any). If a writing group has not been formed, the Steering Committee will make the selection of the presenter. In general, this will be the person proposing the abstract. Regardless of who selects the presenter, the selection must be approved by the Steering Committee.
IV.4.5.8. Invitations to Investigators for Presentation of Materials
The OPT study group welcomes opportunities to participate and present reports at national and international scientific meetings. When a member of the group receives an invitation, policies with regard to publications and presentations must be followed.
1. When a personal invitational is received by a OPT trial investigator to make a presentation, this invitation shall be sent to the Steering Committee for review and approval.
2. When an invitation is extended to more than one investigator, or if it comes to the Chairperson of the Steering Committee, requesting a representative of the study, the Steering Committee shall decide who will represent the OPT study.
3. All presentations in response to such invitations are to be based on published prior reports unless approved beforehand by the Steering Committee.
4. Any presentation of unpublished data must be reviewed and approved by the Steering Committee prior to the date of presentation.
5. Requests received by Principal Investigators or their staff, to present or discuss at local meetings (city, state, or regional) any previously published data, need no prior clearance by the Steering Committee. All local presentations must be reviewed and approved by the Principal Investigator for the center making the presentation. Investigators should be encouraged to accept such invitations. It is requested that principal investigators receiving such requests notify the Administrative Center so the Center can keep record of these presentations.
IV.4.5.9. Use of OPT study material for graduate student theses or dissertations
The Steering Committee will review all requests for use of data by students.
1. The student requesting data must be associated with an investigator in the OPT trial. The investigator shall act as the student's "sponsor" with regard to the data request.
2. Students may not use data if the data related to the main paper are in progress or if the Steering Committee deems the data necessary for a future paper.
3. If the Steering Committee recommends approval for the use of the requested data, a review group will be established and will include the student as convener of the group.

4. The review group will take no action regarding the paper until the student has completed and defended the thesis or dissertation, provided this occurs in a reasonable length of time (the student's sponsor will be requested to report on the student's progress to the Steering Committee).


5. The student must include in the completed thesis the following: 1) a statement acknowledging the OPT study for use of the data; 2) a statement indicating that opinions, ideas, and interpretations included in the thesis or dissertations are those of the student alone and not necessarily those of the OPT Investigators.
6. When the thesis or dissertation has been completed as determined by the sponsor, the dissertation review group will proceed to prepare the paper(s) for publication. A writing group will be formally constituted and will be composed primarily of dissertation review group members. The student should be given the opportunity to take the lead on the paper.
7. The standard publication policy will apply to any material published from the thesis or dissertation.
8. The OPT Study Group reserves the right to proceed with preparing a paper for publication on the thesis or dissertation topic if, in the view of the Steering Committee, the student has not made reasonable progress on completing the thesis or dissertation.
IV.4.5.10. Other Papers, Presentations and Other Matters
1. Members of OPT study group who identify additional papers that draw on data collected by all centers should communicate in writing the general topic or title of the paper they wish to have considered for publication to the chairperson of the Steering Committee. The proposal should state the rationale, background, hypothesis or purpose, and methods. Upon receipt, the policy and procedures described above shall apply.
2. If a specific writing group decides that the topic or charge to that writing group is too broad and should be divided into two or more papers, the writing group (through its lead person) shall communicate with the chairperson of the Steering Committee indicating the writing group's recommendation for the division of the paper into two or more components. The writing group is to identify which of the components it believes are its responsibilities, and to suggest titles and outlines for the other components. The Steering Committee shall consider these recommendations and, when appropriate, redefine the charge to the respective writing group, following which the above specified policy and procedure will apply.
3. Topics, titles, or papers, either directly or indirectly related to the charge of that specific writing group, the lead person of the writing group is to communicate these suggestions to the chairperson of the Steering Committee, following which above specified policy and procedures are to apply.
4. Papers and presentations being developed, based on special data sets by centers involved in sub-studies or ancillary studies, are to be reviewed by the Steering Committee. In general, the writing group, which will prepare such a report, must consist of individuals designated by the participating center(s). The authorship of such a report is to be designated in the usual manner for a scientific report, with the order of names appearing after the title to be decided upon by the participating center(s). The Steering Committee may act as referee, if requested, to help resolve the order of names of authors. In addition to a statement of authorship, such a paper is to have a clear statement that this work was a sub-study or ancillary study of OPT and the appropriate grant support is to be acknowledged. Upon approval of the paper by the Steering Committee, the paper must be submitted to the DSMB members for review and approval.
5. At the end of the list of the paper's authors, an asterisk is to appear for a footnote designating that this work was performed as part of OPT, as a sub-study, an ancillary study or an analysis of local data. Where appropriate, a listing of participating centers and participants who are not authors (generally not more than three persons from each center) is to be included.
6. Local centers are permitted, indeed encouraged, to write papers on local data and experience. A local paper dealing with a matter of a mainstream paper should be prepared only after the respective mainstream paper, based on national experience, has been published or has been officially accepted for publication. The authorship of a local paper is to be dealt with at the discretion of the Principal Investigator of the respective center.
IV.4.5.11. Administrative Procedures
The Steering Committee will hold meetings via teleconference call and email to:
a. Monitor the status of publications and presentation,

b. Approve requests for new papers, presentations, publications or abstracts, and

c. Formulate the content of reports on the status of publications and presentations.
The Steering Committee will have a vice-chairman who will act on behalf of the Chairman in his/her absence to expedite flow of activities with regards to presentations and publications.
IV.4.6. Ancillary Studies Policy
(Adapted with permission from the University of Minnesota "Oral Infections and Vascular Risk in Seven Countries Policy" study.)
The Obstetrics and Periodontal Therapy (OPT) Study may create opportunities for ancillary studies that leverage the main study's subject population or dataset. The objectives of the OPT Study policy on ancillary studies are:
• To encourage ancillary studies that enhance the main study's value;

• To provide an orderly approval process for ancillary studies; and

• To assure that ancillary studies are scientifically sound and do not interfere with

the conduct of the main study or jeopardize the main study's goals.


The specific policies are as follows.
1. Proposals for ancillary studies will be submitted in writing to the Steering Committee (SC) for review. The proposer must be identified.


  1. Proposals will be considered for two types of ancillary studies: i) Data Analysis studies requiring additional analytical resources beyond those already available in the main grant, and ii) New Data Acquisition studies requiring data collection beyond that collected for the main study.

3. Upon approval by the Steering Committee, the study will be presented to the DSMB for review and discussion. Once approval for the study has been granted by the Steering Committee and the DSMB, the study may commence.


4. Ancillary studies enhancing the value of the OPT study are encouraged but must not interfere with the conduct of the main study or in any way jeopardize the main study's goals. Funding may be needed and is the responsibility of the proposer. The SC is charged with evaluating the desirability of ancillary study results and with assessing the acceptability of additional demands on staff and patients, adequacy of estimates of funds and their likelihood of availability, risk to the participants and to the primary study goals, and the overall chances for success. If additional funds are required to conduct an approved ancillary study, these must be obtained through the traditional grant process or from sources other than the cooperative agreement supporting the OPT Trial. Requests to NIDCR for supplemental funds under the cooperative agreement to support ancillary studies will be entertained only under exceptional circumstances.
5. The principal proposer of an approved ancillary study will serve as the lead member of the writing group for papers based on that ancillary study. The proposer will notify the SC of the intent to prepare papers or presentations on the ancillary study.
6. Selection of a writing group, preparation and submission of papers, and submission of abstracts will follow the guidelines for other OPT papers as outlined in Section IV.4.5 "Publications and Presentations".



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