Determine Submission Type and Required Documents
Please review the below guide to determine your review type, what to send the ARC first, and expected timelines.
There are three requirements to be approved as an investigator or research personnel on a study that uses identifiable data or specimens from humans. These include:
Please review this document to identify the path your study will take from the time of first submission to the point in which you can begin enrolling patients, i.e. when your study is "Open to Accrual".
The following process maps have been created to provide detailed information about the corresponding pieces of the overall pathway mentioned above:
Please review the below guide to determine your review type, what to send the ARC first, and expected timelines.
Submit your materials to obgynarc@cuanschutz.edu as soon as possible in order for assistance with the following steps required for study approval. The ARC team may request a meeting to go over the study, or may submit questions to you by email. In any case, there will likely need to be changes or additional clarifications needed, so involving them as early as possible will reduce your timelines.
Pricing and Study Budgets:
Email the ARC for assistance in obtaining pricing and the development of your study budget.
The first step of any proposal is to make a determination on whether it needs to be reviewed for scientific merit. If your proposal is investigator-initiated, it will need to be reviewed by the Scientific Advisory and Review Committee (SARC) unless it has had a full peer-review, such as NIH-funded protocols. Such protocols that have received peer review undergo an expedited review process. However, if you make major scientific changes to a protocol post-peer review, it will need to be reviewed by SARC. This decision tool can be used to assist you in making the determination.
Please see the below link for current SARC submission deadlines. The ARC will facilitate your submission to SARC (see step 2).
Industry-initiated protocols do not require SARC review. Please see below for more information on the pathway that an industry-funded protocol will take.
In order to begin the process of regulatory review, a submission to the Human Subjects Research (HSR) Portal is generally required if visits, recruitment, or data gathering will occur at UCH*, CHCO, and/or UCD. In addition, if you will use CTRC services, your protocol must be submitted through the Portal for feasibility and/or scientific review. In order to submit for this first phase of review you will need the following information, which can be sent to the ARC for the development of your submission materials:
* A separate submission to UCH will be required to obtain clinic manager sign-offs for all UCH procedures, including labs, pharmacy, and enrollment/procedures in specific clinics.
The HSR submission will be reviewed and a "clearance to submit to the IRB" memo will be issued by email.
During the HSR review, the ARC will assist you in the development of your study materials (see list below). At this time the ARC will make a recommendation on whether your study will need review by the full board, or can be submitted as exempt or expedited (single reviewer). The team may request a meeting to go over the study details, or may submit questions to you by email.
Upon receipt of the "clearance to submit to the IRB" from the HSR portal and finalization of all study documents, your study will be submitted for IRB review by the ARC. The following documents must be submitted with your IRB application:
Full board and expedited reviews take approximately 6-8 weeks for initial submissions. Studies that qualify for exempt review, or those submitting for a determination of QA/QI, Program Evaluation, or non-human subjects research may take less time. The timeline for amendment approvals varies depending on the content of the amendment.
Upon initial review, it is likely the IRB will request either minor or major modifications. All issues must be addressed in a point-by-point fashion, and the ARC will facilitate this response. You can expect an email from them detailing the information they will need from you within 48 hours of receipt of the IRB memo.
You will be notified by email of IRB approval. The ARC will download and send all study documents to you by email. It will be your responsibility (or your delegate's) to store copies of these materials in your e-files and regulatory binders.
Amendments: Any changes must be approved by the IRB (and CTRC/SARC if applicable) PRIOR to initiation. All revised documents must be submitted in duplicate: a "clean" copy, and a copy indicating all changes using the "track changes" function. In addition, all changes must be detailed on a "change form". Submit a description of your change to the ARC by email and they will help you develop the new materials.
Continuing Reviews: Approval is typically granted in 12-month cycles. You will be required to submit a continuing review approximately 45 days prior to the anniversary date of your last approval. COMIRB will begin sending reminder notifications approximately 90 days prior to this date. The ARC will assist you in the preparation and submission of your continuing review. You can expect an email from them approximately 1-2 weeks after receipt of your first reminder notice.
Unanticipated Problems (including Adverse Events and Severe Adverse Events): Adverse events that are deemed by the PI to be probably or definitely related to the research procedures must be submitted within 5 days of learning of the event. Submit your narrative to the ARC as soon as possible, and they will assist in completing the required forms and submitting the event on your behalf. A PI signature in the form of a PI attestation will be required, which can be submitted by "wet ink" or electronically by email to the ARC.
Any other events, including protocol deviations and violations will need to be reported at the time of annual review in aggregate form. Click here for a tracking template. If your study has a Data Safety Monitoring Board (DSMB) or safety officer you will need to provide a copy of your report with your continuing review submission.
Study Monitoring: Your study may be monitored by a Sponsor delegate if industry-funded. Investigator-initiated studies, particularly those conducted under an IND, will have a quality assurance review conducted by the Clinical Research Support Center (CRSC). FDA regulated studies may be audited by the FDA at any time. Be sure to alert the ARC of any audits. In addition, the ARC can conduct a "pre-audit" of your study prior to external parties conducting an audit.
Descriptive Statistics Using Excel and Stata (princeton.edu)
Tips for Doing Statistics in Excel (utexas.edu)
Health Statistics (thelancet.com)
Epidemiology 2005 (thelancet.com)
VassarStats: Website for Statistical Computation (vassarstats.net)
Java Applets for Power and Sample Size (uiowa.edu)
For statistical support and study design consultation, contact:
Jeanelle Sheeder, MSPH, PhD
Professor and Associate Vice Chair of Clinical Research
Departments of Obstetrics and Gynecology and Pediatrics
Phone: (303) 724-2272
The Scientific Editor provides Department of Obstetrics and Gynecology faculty members, fellows, residents, and graduate students with editing and analysis for grant applications and peer-reviewed publications – at the levels of both scientific content and writing. The goal of this feedback is to enhance the success of grant applications getting funded and research articles published.
Depending on the type of document (grant or manuscript) and stage of draft, the Scientific Editor can assist with the following feedback:
Writing Mechanics – editing for grammar and typographical errors
Style and Clarity – improving sentence structure, flow, and single voice when multiple authors
Scientific Significance and Impact – strengthening science, research design, and/or overall impact
Presentation – addressing issues related to formatting, word count, use of tables/figures, and guidelines
Interpreting Review Feedback – addressing critiques from peer reviews and formulating response to reviewers
Please submit all documents for editing in Microsoft Word. Depending on the type of editing requested, be prepared to submit the following items. For questions about documents for your specific editing request, please consult Dr. Aldrich.
Grants | Manuscripts or Abstracts |
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The most effective feedback can be provided when the process is started at least two months before a deadline to allow for multiple revisions. Even if you do not have a draft ready for review, please contact Dr. Aldrich as soon as possible to discuss your project and timeline.
Heather Aldrich, PhD
Scientific Editor
Department of Obstetrics and Gynecology
Phone: (303) 724-3557
Heather Aldrich, PhD
July 25, 2022
Whether someone is working on a grant, updating a biosketch, writing a manuscript, or preparing an abstract, a common question is, “when should I send it to you for editing?”
Scientific editing can be utilized at any stage of the writing process - from pre-writing support to well-developed drafts to resubmissions. The focus of editing is different at different stages of writing, so the optimal time may vary by author, project, and timeline.
Editing can begin even before actual writing occurs. There are many terms for this stage - taking notes, brainstorming, and I usually refer to it as “pre-writing.” At this pre-draft stage, some ways an editor can assist authors is by discussing outline content, visuals, and scope of the writing project. For scientific writing, it can also be helpful to address ways to tailor a topic to a specific funding announcement or journal.
Once a document moves into an early draft or more well-developed draft, scientific editing can provide feedback related to style, clarity, and presentation. Additionally, a scientific editor can provide suggestions for strengthening scientific significance and overall impact. At this stage, there are often comments related to presentation, scope, organization, and formatting.
People often think of editing as the last stage of the writing process. A final editing step can be helpful - it is a chance to catch typographical errors, modify minor grammar gaffes, and polish punctuation. However, the final editing step, also called proofreading, is not the ideal time to address major structure, organization, clarity, or style issues.
Finally, many forms of scientific writing require resubmissions. The focus of editing resubmission drafts can include suggestions for addressing reviewer critiques and feedback on an author's response to reviewers. Based on the project and timeline, scientific editing can occur at multiple draft stages.
While the focus of scientific editing varies along the writing continuum, the goal remains the same - to help investigators clearly and concisely communicate their scientific work to enhance funding or publication success. Please let me know if you have questions, ideas, or would like to discuss your upcoming writing project. More information about the Department of Obstetrics and Gynecology Scientific Editing Services can be found here.
Heather Aldrich, PhD
April 26, 2022
Abbreviations are commonly used in scientific writing. “Abbreviation” generally refers to all shortened words or phrases, though many abbreviations in scientific writing are acronyms or initialisms. While abbreviations in scientific writing can be useful and save space, they can easily cause confusion and make a reader's job more difficult.
To help determine whether to use an abbreviation, consider:
Tips when working with abbreviations:
For more information or to submit requests for scientific editing visit: medschool.cuanschutz.edu/ob-gyn/scientific-editing