Applied Clinical Research, Clinical Trials and Regulatory Affairs

Authors who publish in Bentham Science print & online journals will transfer copyright to their work to Bentham Science Publishers. Submission of a manuscript to the respective journals implies that all authors have read and agreed to the content of the Copyright Letter or the Terms and Conditions. It is a condition of publication that manuscripts submitted to this journal have not been published and will not be simultaneously submitted or published elsewhere. Plagiarism is strictly forbidden, and by submitting the article for publication the authors agree that the publishers have the legal right to take appropriate action against the authors, if plagiarism or fabricated information is discovered. By submitting a manuscript, the authors agree that the copyright of their article is transferred to the publishers if and when the article is accepted for publication. Once submitted to the journal, the author will not withdraw their manuscript at any stage prior to publication.

It is mandatory that a signed copyright letter also be submitted along with the manuscript by the author to whom correspondence is to be addressed. The article should not contain any such material or information that may be unlawful, defamatory, fabricated, plagiarized, or which would, if published, in any way whatsoever, violate the terms and conditions as laid down in the copyright agreement. Copyright letter can be downloaded from the journal's Web site. Download the Copyright letter.

Permission to Reuse Bentham Content

Bentham Science has collaborated with the Copyright Clearance Center to meet our customer’s licensing, besides rights & permission needs.

The Copyright Clearance Center’s RightsLink® service makes it faster and easier to secure permission from Bentham Science’s journal titles. Visit Journals by Title and locate the desired content. Then go to the article’s abstract and click on “Rights and Permissions” to open the RightsLink’s page. If authors can't find the content they are looking for or can't get the rights they need, please contact us at [email protected]

Third-Party Permissions

Authors are responsible for managing the inclusion of third-party content as an author/editor of a work. We refer to 'third party content' as any work that authors haven't developed themselves and have copied or adapted from other sources. Text, figures, photographs, tables, screenshots, and other items may be included.

Unless the figure is in the public domain (copyright-free) or permitted for use under Creative Commons or other open licences, the author must get permission from the copyright holder(s).

Published/reproduced material should not be included unless written permission has been obtained from the copyright holder, which should be forwarded to the Editorial Office in case of acceptance of the article for publication.

By signing the Copyright Letter the authors retain the rights of self-archiving. Following are the important features of self-archiving policy of Bentham Science journals

These peer reviewed issues will either contain invited review/mini-review articles or a mixture of review articles and drug clinical trial studies. A Single Topic Issue Editor will offer a short perspective and co-ordinate the solicitation of manuscripts between 3-5 (for a mini-thematic Issue) to 6-10 (for a full-length thematic Issue) from leading experts in the specified area. Authors interested in editing a single topic issue in an emerging field of clinical drug development, research, clinical trials, regulatory affairs and medical education research between high growth and potentially growing regions may submit their proposal to the Editor-in-Chief at [email protected] for consideration.

For proposals to publish conference proceedings in this journal, please contact us at email: [email protected]

There is no restriction on the number of figures, tables or additional files e.g. video clips, animation and datasets, that can be included with each article online. Authors should include all relevant supporting data with each article (Refer to Supplementary Material section).

It is advisable that authors prepare their manuscript using the template available on the Web, which will assist in preparation of the manuscript according to journal’s format. ownload the Template.

Manuscripts submitted for research and review articles in the journal should be divided into the following sections:

Financial contributions and any potential conflict of interest must be clearly acknowledged under the heading ‘Conflict of Interest’. Authors must list the source(s) of funding for the study. This should be done for each author.

Any research assistants or other individuals who assisted with the research but are not listed as authors, such as those who carried out the literature review, produced, computerized, and analyzed the data, or helped with the language, writing, or proofreading of the article, or offered any comments or suggestions, should be acknowledged. Briefly, everyone who has contributed significantly to the improvement of the paper should be acknowledged. It is recommended to mention the "Declared None" if there is no acknowledgement for the study.

Guest or honorary authorship based solely on position (e.g. research supervisor, departmental head) is discouraged.

The specific requirements for authorship have been defined by the International Committee of Medical Journal Editors (www.icmje.org). Examples of authors' contributions are: 'designed research/study', 'performed research/study', 'contributed important reagents', 'collected data', 'analyzed data', 'wrote paper' etc. This information must be included in the submitted manuscript as a separate paragraph under the heading 'Authors' Contribution'. The corresponding author is responsible for obtaining permission from all co-authors for the submission of any version of the manuscript and for any changes in the authorship.

Compliance with the guidelines of the International Committee of Medical Journal Editors (www.icmje.org) is recommended, in accordance with the patient’s consent for research or participation in a study as per the applicable laws and regulations regarding the privacy and/or security of personal information, including, but not limited to, the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and other U.S. federal and state laws relating to confidentiality and security of personally distinguishable evidence, the General Data Protection Regulation (GDPR) (EU) 2016/679 and member state implementing legislation, Canada's Personal Information Protection and Electronic Documents Act, India's Information Technology Act and related Privacy Rules, (together "Data Protection and Privacy Laws").

It is the responsibility of the author to ensure that:

Editors may request that authors provide documentation of the formal review and recommendation from the institutional review board or ethics committee responsible for oversight of the study. The editors reserve the right to reject manuscripts that do not comply with the above-mentioned requirements. The author will be held responsible for false statements or failure to fulfill the above-mentioned requirements.

For research involving animals, the authors should indicate whether the procedures followed were in accordance with the standards set forth in the eighth edition of “Guide for the Care and Use of Laboratory Animals” (grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals_prepub.pdf published by the National Academy of Sciences, The National Academies Press, Washington, D.C.).

Research work on animals should be carried out in accordance with the NC3Rs ARRIVE Guidelines. For In Vivo Experiments, please visit https://www.nc3rs.org.uk/arrive-guidelines

Authors should clearly state the name of the approval committee, highlighting that legal and ethical approvals were obtained prior to initiation of the research work carried out on animals, and that the experiments were performed in accordance with the relevant guidelines and regulations stated below.

All experimental research on plants (either cultivated or wild), should comply with international guidelines. The manuscript should include a declaration of compliance of field studies with relevant guidelines and/or relevant permissions or licenses obtained by the IUCN Policy Statement on Research Involving Species at Risk of Extinction and the Convention on the Trade in Endangered Species of Wild Fauna and Flora.

Any unusual risks associated with the use of any chemicals, procedures, or equipment used in the work must be explicitly stated by the author in the manuscript, preferably in both the materials and methods section and the declaration section. For more information, visit The World Medical Association (https://www.wma.net/what-we-do/public-health/chemicals)

Unethical behavior and misconduct may be pointed out by anyone to the Editor and Publisher with sufficient evidences. The Editor, in consultation with the Publisher, will initiate investigation against this Unethical misconduct, complete the procedure till an unbiased decision is reached, and maintain confidentiality throughout the process of the investigation. The Author should be given the opportunity to reply to all minor or major accusations.

In case of serious breaches, the employer may be informed where appropriate, by the Editor/Publisher, after reviewing all available information and evidences or after seeking help from experts in that field.

If the manuscript has an individuals’ data, such as personal detail, audio-video material etc., consent should be obtained from that individual. In case of children, consent should be obtained from the parent or the legal guardian.

All such case reports should be followed by a proper consent prior to publishing.

In ACS style, all references should be numbered sequentially [in square brackets] in the text and listed in the same numerical order in the reference section. Superscript in the in-text citations and reference section should be avoided.

In Vancouver style, all references should be numbered sequentially [in square brackets] in the text and listed in the same numerical order in the reference section. Punctuation should be properly applied as mentioned in the examples given above.

The four types of research data policies are mentioned below.

Wherever appropriate and possible, the journal encourages authors to publish data to support their research findings in a public repository. Any datasets mentioned in the article that are available in external repositories should be cited.

How to Cite the Data?

Whether the data was developed by the author(s) or researcher(s), all publicly available data referenced in the preparation of an article should be cited in the text and reference list. The references relating to the data availability should be presented in the following format:

Example: Name of author(s), the title of data set, data repository, document version (e.g., most recent updated version), Digital Object Identifier (DOI), and Bentham Science reference style should be included in data citations.

When authors submit a paper to a journal, the authors agree that the data provided in the publication, including the relevant raw data, will be freely available to any researcher who wants to use these for non-commercial reasons without jeopardising participant anonymity.

Data availability declarations are required under Bentham Science research data policy types.

The statement relating to the data availability should be presented in the following format under a separate section for ‘Availability of Data and Materials’ in the manuscript:

Additional Data Availability Statements

Authors can add or change the statement(s) above, to fit their work the best. Depending on the nature of the research, several assertions may need to be merged.

All datasets on which the paper's conclusions are based must be made accessible to reviewers and readers, according to the journal's rules. Prior to peer review, authors must either deposit their datasets in publicly accessible repositories or provide them as supplementary materials with their submission. For further details, please visit complete guidelines at: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html

Authors may provide the raw data in connection with a paper for editorial review, and should be prepared to provide public access to such data. if practicable, and should in any event be prepared to retain such data for a reasonable time after publication.

All authors must strictly follow the guidelines below for preparing illustrations for publication in Applied Clinical Research, Clinical Trials and Regulatory Affairs . If the figures are found to be sub-standard, then the manuscripts will be rejected.

The authors are expected to submit good quality figure(s) in PDF, PPT, MS Word, TIFF or JPEG versions, which, if required, should be improved yourself or by professional graphic designers of your organization/country. You may even consider approaching our contracted service providers Eureka Science for Graphics Enhancement Services.

The Graphics Designing team at Eureka Science can assist in improving the quality of your images at affordable rates. Eureka Science has contracted special rates with us of US $135 for the improvement of up to five figures, with any additional figures being charged at US $20 each.

The quality of Graphic Enhancement Services offered by Eureka Science can be viewed at http://www.eureka-science.com/images/Binder1.pdf, along with valuable feedback on their services at http://www.eureka-science.com/testimonials.php. You may contact Eureka Science at [email protected]

Note: Availing Graphics Enhancement Services does not guarantee acceptance of the manuscript for publication. The final acceptance/decision on the manuscript is taken by the EiC.

Bentham Science Publishers requires that all individuals listed as authors must have made a substantial contribution to the design, performance, analysis, or reporting of the work. The role of authors is judged on the basis of ICMJE and COPE guidelines.

All contributing authors are required to sign a copyright letter, mentioning complete details, including full name, affiliation, email address, ORCID ID and their role in the article. After successful electronic submission of a manuscript, a system-generated acknowledgement will be sent to all authors on their provided email addresses.

The Corresponding Author must provide a final list of authors at the time of submission, ensuring the correct sequence of the names of authors, which will not be considered for any addition, deletion or rearrangement after final submission of the manuscript. The email address of the principal author should be provided with an asterisk. However, the complete address, business telephone numbers, fax numbers and e-mail address of the corresponding author must be stated to receive correspondence and galley proofs. Bentham Science Publishers recommends that all contributors regularly update their profiles on SCOPUS/ORCID and other databases.

The corresponding author must have the approval of all other listed authors for the submission and publication of all versions of the manuscript.

Authors are strongly recommended to use their ORCID ID when submitting an article for consideration. Alternatively, they can acquire an ORCID ID via the submission process. For more information about ORCID IDs, visit here.

At the time of initial submission, the finalized list of authors in correct sequence should be provided, which will not be changed once the publication process has started.

If any change is essential, then it can only be done after the approval of the Editor-in-Chief upon receiving the following details from the corresponding author:

1. The reason for the change in the author list and/or their sequence
• A proper justification should be provided for changes in authorship.
• Correction of existing names should be accompanied by a notice to the Editor-in-Chief of the journal.
2. A written confirmation from all the co-authors is a prerequisite for any amendment or removal.

Any amendment to the authors' list will only be considered and approved by the Editor-in-Chief after complete verification. Publication of the manuscript will be withheld during consideration of the request. However, if the manuscript has already been published online, requests approved thereafter by the Editor-in-Chief will result in an erratum or corrigendum. The corresponding author is responsible for obtaining permission from all co-authors for any changes in the authorship.

Here is some advice by COPE on authorship issues. Bentham strives to follow these guidelines.

Bentham Science Publishers recognizes that authors use a variety of tools for preparing articles related to their scientific works, ranging from simple ones to very sophisticated ones.

According to the COPE (Committee on Publication Ethics) guidelines, "AI tools cannot meet the requirements for authorship as they cannot take responsibility for the submitted work. As non-legal entities, they cannot assert the presence or absence of conflicts of interest nor manage copyright and license agreements".

The pertinence of such tools may vary and evolve with public opinion, due to which the use of AI-powered language tools has led to a significant debate. These tools may generate useful results, but they can also lead to errors or misleading results; therefore, it is important to know which tools were used for evaluating and interpreting a particular scientific work.

Considering the above we require that:

1. The authors to report any significant use of such tools in their works, such as instruments and software along with text-to-text generative AI consistent with subject standards for methodology.
2. All co-authors should sign a declaration that they take full responsibility for all of its contents, regardless of how the contents were generated. Inappropriate language, plagiarized and biased contents, errors, mistakes, incorrect references, or misleading content generated by AI language tools and the relevant results reported in scientific works are the full and shared responsibility of all the authors, including co-authors.
3. AI language tools should not be listed as an author; instead, authors should follow clause (1) above.

Authors will receive page proofs of their accepted paper before publications. To avoid delays in publication, proofs should be checked immediately for typographical errors and returned within 48 hours. Major changes are not acceptable at the proof stage.

The corresponding author will be solely responsible for ensuring that the revised version of the manuscript incorporating all the submitted corrections receives the approval of all the co-authors of the manuscript.

No page charges will be levied to authors for the publication of their article. However, the authors may decide for some paid-for editorial services such as open access publication and/or a faster overall publication for their article(s).

For this journal an optional fast publication fee-based service called QUICK TRACK is available to authors for their submitted manuscripts.

QUICK TRACK allows online publication within 2 weeks of receipt of the final approved galley proofs from the authors. Similarly the manuscript can be published in the next forthcoming PRINT issue of the journal. The total publication time, from date of first receipt of manuscript to its online publication is 12 weeks, subject to its acceptance by the referees and modification (if any) by the authors within one week.

The author will be initially charged a small fee on receipt of the agreement form for Quick Track publication to partially cover the initial costs incurred for expedited processing of the submitted manuscript. Later, the full Quick Track publication fee (US$ 52 per composed page charges) will be payable in advance, after acceptance of the manuscript, before online publication of the article. However, if the article is rejected at the peer-review stage, then the US$ 52 per composed page charges will not be charged.

Please note that whether the author opts for the QUICK TRACK facility or not, standard reviewing practices will be followed, which will not in any way affect the acceptance or rejection of the manuscript by the reviewers.

Authors who have availed QUICK TRACK services in a BSP journal will be entitled for an exclusive 30% discount if they again wish to avail the same services in any Bentham journal.

For more information please contact the Editorial Office by e-mail at [email protected].

Bentham Science offers a 50% discount off the Quick Track Publication Fee for manuscripts of all corresponding authors who reside in countries which are categorized as low-income economies by the World Bank. To see if you qualify to the discount, please refer to the complete list of these countries click here.

Bentham Science offers three major services related to its publications:

• Subscription services (to subscribers, institutes, libraries, customers, etc.): Involving access to published content based on certain charges for corporates, academic institutes, and individuals.
• Editorial / Author Pre-publication services (to editors, authors, etc.): Quick track processing, language editing, etc.
• Editorial / Author Post-publication Promotional Services (to authors, institutions and organizations): Open Access Plus, Animated Abstracts, Sharing PDF on KUDOS, reprints, etc.

Since these services are optional in nature and are offered for specific services rendered, hence refunds are not allowed against the availed and charged services, except under special cases.

Bentham Science also offers authors the choice of “Open Access Plus (Gold Open Access)” publication of articles at a fee of US$ 400 per article. This paid service allows for articles to be disseminated to a much wider audience, on the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0) (https://creativecommons.org/licenses/by/4.0/legalcode). Authors are asked to indicate whether or not they wish to pay to have their article made more widely available on this “Open Access Plus (Gold Open Access)” basis. Where an author does not opt-in to this paid service, then the author’s article will be published only on Bentham Science’s standard subscription-based access, at no additional cost to the author.

Authors who select the “Quick Track” publication option and also wish to have their article made available on an “Open Access Plus (Gold Open Access)” basis will be entitled to a 50% discount on the “Open Access Plus (Gold Open Access)” publication fee.

For more information please contact us at e-mail: [email protected]

Bentham Science offers a 50% discount off the Open Access Plus (Gold Open Access) Fee for manuscripts of all corresponding authors who reside in countries which are categorized as low-income economies by the World Bank. To see if you qualify to the discount, please refer to the complete list of these countries click here.

Printed reprints and e-prints may be ordered from the Publisher prior to publication of the article. First named authors may also order a personal print and online subscription of the journal at 50% off the normal subscription rate by contacting the subscription department at e-mail: [email protected].

Bentham Science offers 50% discount on the Open Access Plus (Gold Open Access) Fee, Quick Track Fee and Article Processing Charges (APC) for manuscripts of the corresponding authors based in countries categorized as low-income economies by World Bank (list given below).

For any query or suggestion, please contact us on [email protected].

The text of every submitted manuscript is checked by using the Content Tracking mode in iThenticate. The Content Tracking mode ensures that manuscripts with an overall low percentage similarity (but which may have a higher similarity from a single source) are not overlooked. If the similarity level is significantly high, then the manuscript is returned to the author for paraphrasing the text and citing the original source of the copied material.

It is important to mention that the text taken from different sources with an overall low similarity percentage will be considered as a plagiarized content if the majority of the article is a combination of copied material.

There may be some manuscripts with an overall low similarity percentage, but a higher percentage from a single source. For instance, a manuscript may have less than 20% overall similarity but there may be 15 % similar text taken from a single article; the similarity index in such cases is higher than the approved limit for a single source. Authors are advised to thoroughly rephrase the similar text and properly cite the original source to avoid plagiarism and copyright violation.

We all know that scholarly manuscripts are written after a thorough review of previously published articles. It is therefore, not easy to draw a clear boundary between legitimate representation and plagiarism. However, the following important features can assist in identifying different kinds of plagiarized content. These are:

Published manuscripts which are found to contain plagiarized text are retracted from the journal website after careful investigation and approval by the Editor-in-Chief of the journal. A ‘Retraction Note’ as well as a link to the original article is published on the electronic version of the plagiarized manuscript and an addendum with retraction notification in the journal concerned.

For further details, please visit: https://www.benthamscience.com/research-misconduct

Articles appearing in E-Pub Ahead-of-Schedule sections have been peer-reviewed and accepted for publication in this journal and posted online before scheduled publication. Articles appearing here may contain statements, opinions, and information that have errors in facts, figures, or interpretation. Accordingly, Bentham Science Publishers, the editors and authors and their respective employees are not responsible or liable for the use of any such inaccurate or misleading data, opinion or information contained of articles in the E-Pub Ahead-of-Schedule.