Research Toolkit

Requirements for Human Subjects Researchers/Personnel

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:

  1. Submit a Conflict of Interest (COI) disclosure.
  2. Upload your CV into the InfoEd system.
    • Go to InfoEd eRA
    • Select your campus to log in (Denver).
    • Login using your CU Anschutz username and password.
    • In the top menu bar, select “My Profile”.
    • Under "Biography" on the left had menu, select "Biosketch".
    • Select add, and follow the directions.
  3. Complete applicable human subjects protections courses through CITI. Visit the Colorado Multiple Institutional Review Board (COMIRB) Training Page for information on accessing the following courses:
    • Everyone must complete:
      • Group 1 Biomedical Investigators
      • CITI Health Information Privacy and Security (HIPS) for Clinical Investigators
    • If your study is funded by the NIH:
      • Group 4: ICH/GCP – meets NIH Requirements
    • If your study is funded by Industry, you may need to complete:
      • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
        (depending on Sponsor requirements)
    • If you are the PI of a study with a drug or device, you will need to complete:
      • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)

Process Maps

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:

1

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.

2

Submit to Administrative Research Core (ARC)

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.

3

Scientific Review

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.

4

Submit a Research Protocol

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:

  1. Title and list of study personnel.
  2. Protocol.
  3. Calendar of Events demonstrating which procedures are done as SOC and which are research only.
  4. Funding source.
  5. Subject population and anticipated enrollment.
  6. Planned recruitment period.
  7. List of all study sites where procedures will occur.
  8. Contract and consent (draft acceptable) for industry-funded studies.
  9. CTRC services request(s), if applicable.

* 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.

5

IRB Submission

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:

  1. Protocol.
  2. Protocol application for review.
  3. Consent documents, or justification for a waiver of consent.
  4. Any "subject facing" documents, including advertisements, surveys, diaries, informational materials, etc.
  5. Data collection tool for secondary analysis studies (list of variables to collect).
  6. PI attestation signed by the PI.
  7. Mentorship agreement signed by the PI and mentor for studies in which the PI is a student or trainee
6

IRB Review & Approval

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.

7

Post-Approval Responsibilities

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.

Online Resources

Descriptive Statistics Using Excel and Stata (princeton.edu)

Tips for Doing Statistics in Excel (utexas.edu)

Health Statistics (thelancet.com)

Epidemiology 2005 (thelancet.com)

Online Testing (basic)

QuickCalcs (graphpad.com)

VassarStats: Website for Statistical Computation (vassarstats.net)

Sample Size/Power Calculator

Java Applets for Power and Sample Size (uiowa.edu)


Department of Obstetrics and Gynecology Support

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

 

Contact Info

Pamela Alvarez Moran
Administrative Research Core Manager
12700 East 19th Avenue
Room 3009, MS 8613
Aurora, CO 80045

Phone: (303) 724-6501
Fax: (303) 724-3512

 

 

Contact Info

Pamela Alvarez Moran
Administrative Research Core Manager
12700 East 19th Avenue
Room 3009, MS 8613
Aurora, CO 80045

Phone: (303) 724-6501
Fax: (303) 724-3512