FAQ

How do I get started in conducting research?

If you’re new to clinical research at UH, we have a robust catalog of resources to help you get started. Please refer to the following resources that outline the steps you should take to get started in the UH Research Process:

• New Researcher Checklist
• UH Research Process and Roadmap
• Investigator Training
  • Outline
  • GPS Course (Required for all PI’s)
• GPS Course: Getting Started with your Research
• Research Toolbox can also help you successfully navigate the research process too.

Is there a Sparta IRB Instructions Manual?

Yes. After you log in to SpartaIRB, click on “Help Center” icon which is located on the bottom left hand side. Here you will find helpful guides, which may assist you when submitting to SpartaIRB.

How do I begin to submit a new protocol?

You first have to log in to SpartaIRB which is the electronic system University Hospitals uses for research submissions. Do this by going to https://spartairb.case.edu and sign in using your UH/CWRU username and password. Then on the left hand side click “Library”. The “Library” houses all documents, like templates and policies. Once in the Library you can click on “Templates”. This will bring you to the IRB’s protocol templates. These protocol templates are REQUIRED. You should select the protocol template that is most applicable to your study. For example, if you are planning on conducting a chart review you should select the “HRP-503DATA-Template-Chart Review & Specimens Protocol”. If you cannot figure out which template you should use, feel free to call us. We can help guide you to the correct template.

What happens after I submit?

Once you submit, your study will be assigned to one of our IRB specialists who will perform a “pre-review” on your entire submission. If they find any components missing or need for clarifications, they will send you back to stipulations that must be addressed. Once you have sufficiently addressed all the stipulations, the IRB specialist will either assign your study to a formal IRB board meeting (if your study is greater than minimal risk) or they will expedite your study electronically to an IRB chair for review (if your study is not greater than minimal risk – with few exceptions).

How will I know if there is need for clarifications or when my study is approved?

A notification will be sent to your email that lets you know clarifications have been requested by an IRB specialist. Additionally, if you login into SpartaIRB the state of your submission will be in “Clarification Requested (Pre-Review)”. If your study is reviewed and approved, the IRB specialist will send the approval notification letter via email. The state of your submission will then be in a “Review Complete” state.

How long does it take for a new study to be approved?

This is mainly dependent on how well the initial submission is put together and if there are stipulations sent back to the study team, and how well the study team addresses the stipulations sufficiently. Once the study is in good enough condition to be formally reviewed, it will either be electronically expedited to an IRB reviewer or it will be assigned to the next full board meeting. There is a non-cancer full board meeting every Tuesday and a cancer full board meeting on the 2nd & 4th Thursday of every month. In order to make a full board meeting’s agenda, the submission must be assigned to the meeting ~six days prior to the meeting date (the agenda is sent out prior to the meeting date so that the IRB reviewers have enough time to provide their reviews).

What is the difference between privacy and confidentiality in research?

Privacy: Protects access to persons. It is the right of each person to control access to themselves and their information. Can be thought of as “before you collect the data.”

Confidentiality: Protects access to data. It is the assurance that protected and personal information will not be revealed purposefully or accidentally. Can be thought of as “after you collect the data.”

Reference:

• Clinical Research SOP GA-102 - Use and Disclosure of Protected Health Information Preparatory to Research
• UH Policy R-3
• UH Policy PH-15
• FAQs - Access & Use of Patient Records for Research Purposes

If I’m obtaining written consent from subjects, why did I get a stipulation back from the IRB that I have to apply for a waiver of consent and a partial waiver of HIPAA Authorization?

If you received this stipulation, it is most likely because although you plan to obtain written consent from subjects, you are still accessing patient PHI prior to the consent process to determine subject eligibility. As a result, you may be accessing PHI of patients that you may ultimately deem ineligible for participation and thus never end up consenting.

You must request a Partial Waiver of HIPAA Authorization when accessing patient PHI for pre-screening purposes to determine subject eligibility.

How can I access funding for my research?

Contact ClinicalResearch@UHhospitals.org or visit the Funding Opportunities webpage.

FAQs for Research Mentors

How do I get IRB help?

Call 216-844-1529 or visit the IRB Administration Office during Office Hours. It is also recommended that you sign up for CRC newsletter and news feed by emailing ResearchCompliance@uhhospitals.org.

What training do I need as a mentor?

The “For Researchers” page of the UH Clinical Research section of the website is a helpful place to search for information about the research process at UH and also required trainings. If not already completed, you will need CREC Certification (by taking CITI BASIC) and Investigator Training prior to submitting anything to the IRB. As you likely know, NIH-funded projects require GCP training (ICH – GCP Guidelines). A free option is available within the CITI Program (https://www.citiprogram.org).

What training does my resident or fellow need?

The same training as a mentor in the answer above (in fact everyone listed on the study personnel table needs to be CREC certified.)

What training does my medical student need?

Even if he/she has access to the AEMR or UHCare via clerkships, students are not UH employees and must be Research Credentialed in order to access UH PHI. The research credentialing page of the website details the credentialing process and you can contact the Research Credentialing office at UHResearchCredentialing@UHhospitals.org for help as needed.

What is SpartaIRB and how do I access it?

SpartaIRB is the new electronic IRB submission system. If you do not have an account, there are instructions on the log in page for how to request. You will sign in with either your UH or Case credentials.

There are 2 main tabs: “My Inbox” and “IRB”. If you go to “IRB,” then to “Library” and then to the “General” tab you will find the Investigators Manual for IRB Submissions (HRP-103 – UH Investigator Manual) which has all of the IRB policies in a single document. Use the [Ctrl] F “Find” feature to find information on whatever topic you would like to peruse.

The Investigators Manual for IRB Submissions is also available on the IRB Policies webpage.

How do I get help in SpartaIRB?

Go to “IRB,” then to “Help Center,” and then to “Guides.” There you will find guides for submitting a new protocol, continuing reviews, adding personnel, etc.

What do I actually submit in SpartaIRB?

You will submit your protocol on a template. These templates (protocols, consents, and assents) can be found in the Templates section in the SpartaIRB Library and are REQUIRED for submissions. Note that there are both CWRU and UH templates – wherever there is the option, please choose the UH templates. You are required to submit the templated protocol, any informed consent and/or assent forms, and all “patient-facing” materials (advertising, letters, surveys, etc). You will likely need to submit your data collection forms also (and linking log if using one – ask if unsure).

What is the difference between an Expedited study and an Exempt one?

In general, Exempt studies have to clearly fit into one of the specific Exempt categories and would go on the Exempt protocol template (HRP-503EXEMPT). Exempt studies need to meet certain criteria, and generally, if the data being collected is either sensitive or identifiable, the Expedited review is more appropriate.

Expedited studies include surveys, interview studies, chart reviews, and other not greater than minimal risk studies. Expedited studies are often submitted on a chart review (HRP-503DATA) or a Social, Behavioral and Educational Research template (HRP-503SBER), but please review the descriptions to be sure you use the correct template.

Excellent summaries of each study type can be found here:

• Exempt
• Expedited

Does Quality Improvement work need to be submitted to the IRB?

The IRB always recommends that you submit proposed QI work for a determination of Not Human Research on HRP-503NHR. There may be components of the QI that are research and it can be difficult to see this clearly in your own work. Having a determination ahead of time can ensure you are on the right track.

Do Case Reports need to be submitted to the IRB?

These also should be submitted for a determination of NHR. For 3 cases or less, the NHR submission is correct; if >3 cases (a case series) please submit as Expedited. You will obtain permission from the subject(s) of the case report but not informed consent – this is not an IRB specification but is almost always a requirement of journals.

Quality Improvement FAQs for Clinical Researchers

I am confident my protocol is quality improvement. Why do I need IRB review?

All Quality Improvement protocols should be submitted to the IRB with a request for a determination of “Non-Human Subjects Research.” This is institutional policy. The researcher should not make this determination even when he/she is confident the work is QI, because when information is gathered about human subjects the Code of Federal Regulations regarding Protection of Human Subjects is relevant (45 CFR 46) and compliance with the regulations is a federal mandate.

I don’t want to publish my Quality Improvement project. Do I still need to submit it to IRB?

Yes. Intent to publish does not distinguish Quality Improvement from research, or determine if the protocol is Exempt or not (i.e. Non-Human Subjects Research determination).

So what is the difference between Research and Quality Improvement, anyway?

Research is “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…” (45 CFR 46.102(d)); quality improvement is an activity conducted by one or more institutions “…whose purposes are limited to: (a) implementing a practice to improve the quality of patient care, and (b) collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes”.^*

In other words…
A protocol that has comparative intervention arms (of any type, including behavioral, medical, device related or surgical) is research, and any protocol that tests a new procedure or intervention is likely to be considered research. On the other hand, protocols that apply an already evidence-based intervention or intervention bundle (i.e. one that has been documented as effective in published research trials) to all patients with a specific condition, are likely to be considered quality improvement. In general quality improvement is intended to impact only those individuals who are being treated, whereas research is intended to be generalizable.

^*US Department of Health and Human Services Office of Human Research Protection Quality Improvement FAQ

When is my Quality Improvement project also considered research?

Fortunately the OHRP website has a great Q and A for this, which follows here:

Q: Are there types of quality improvement efforts that are considered to be research that are subject to HHS human subjects regulations?

A: Yes, in certain cases, a quality improvement project may constitute non-exempt human subjects research conducted or supported by HHS or otherwise covered by an applicable FWA. For example, if a project involves introducing an untested clinical intervention for purposes which include not only improving the quality of care but also collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, that quality improvement project may also constitute nonexempt human subjects research under the HHS regulations

Text copied from: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/quality-improvement-activities/index.html

If my Quality Improvement project is NOT determined to be Non-Human Subjects Research, and parts of it are considered research, does this mean I have to obtain informed consent from all subjects (patients and/or providers)?

The short answer is “no”. But again, the OHRP website has the response to this important question, and it just boils down to the HHS requirements for waiving informed consent:

…the HHS regulations protecting human subjects allow an IRB to waive the requirements for obtaining informed consent of the subjects of the research when

1. the risk to the subjects is minimal
2. subjects’ rights and welfare will not be adversely affected by the waiver
3. conducting the research without the waiver is not practicable, and
4. if appropriate, subjects are provided with additional pertinent information after their participation (45 CFR 46.116(d))

Other applicable regulations or laws may require the informed consent of individuals in such projects independent of the HHS regulations for the protection of human subjects in research.

Text copied from: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/quality-improvement-activities/index.html

We are doing a project in which there is an educational offering for residents about errors in medicine, with a pretest and a posttest. Surely this is Quality Improvement!

Not necessarily. Things to consider include: Is the educational offering mandatory or voluntary? Are the pre and posttests being used to evaluate the residents? Recall that trainees and employees are a vulnerable population, so additional protections may be needed.

A protocol which includes educational research may be appropriate for a determination of Exempt status category 1 (“Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

1. research on regular and special education instructional strategies, or;
2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.”)

What if I have more questions?

Talk with your Departmental Review Chairperson, or call the IRB at 216-844-1529. We want to talk to you and help you avoid frustrations!

FAQs About PI Proxy

What is a PI proxy?

A PI proxy is an individual listed on the study's personnel table who has the ability to submit modifications, continuing reviews, study closures and responses to clarifications to the IRB on behalf of the PI.

Is a PI proxy the same thing as a Primary Contact?

No. A PI proxy can submit to the IRB after initial approval and must be assigned by the PI. A Primary Contact can create submissions,but does not have the ability to submit to the IRB.

Anyone can assign Primary Contacts. Both PI proxies and Primary contacts receive email notifications from SpartalRB.

Who can be a PI proxy?

Anyone who is approved on the study's personnel table can be assigned as the PI proxy.

How many people can be PI proxy?

There is no limit to the number of individuals who can be assigned as the PI proxy.

Who can assign a PI proxy?

Only the Principal Investigator of the study can assign a PI proxy.

How do I assign a PI proxy? Do I have to submit a modification to assign a PI proxy?

In SpartaIRB, there is an “Assign PI Proxy” button. The PI can then select anyone from the study table and instantly assign them as a PI.

Please note that the PI must assign the PI proxy from the study’s main workspace. The “Assign PI Proxy” button is not available from Modification or Continuing Review workspaces.

When should I assign a PI proxy?

While the PI can assign a PI proxy at any time, it is suggested that the PI do it on a new study after department review is complete and the study is ready to be submitted to the IRB.

My study is in pre-submission, but I do not have a “Submit button.” How do I submit to the IRB?

Only the PI can submit a new study to the IRB. For follow-on submissions, you will need to do one of these three things:

1. Have the PI submit to the IRB
2. Have the PI proxy submit to the IRB
3. Have the PI assign you as the PI proxy so you can submit

Research Compliance FAQs

Monitoring versus Auditing

Monitoring is defined as “the act of overseeing the progress of a clinical trial, and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s)” ICH E6 5.18

An Audit is defined as “a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), GCP and the applicable regulatory requirement(s)” ICH E6 5.19

How do I prepare for an UH Research Compliance audit visit?

Research compliance reviews and audits are unavoidable when you are engaged in research. At UH, research compliance reviews are an institutional mandate with a focus on decreasing risk to the institution, and ensuring the safety of UH research patients. For UH Research Compliance audit planning purposes:

1. Provide a copy of the current de-identified enrollment log so we can estimate the time needed to complete the review
   • Plan for enough time based on the complexity of the study and the number of study participants enrolled, but be mindful that at least one full day might be needed.
2. Provide date options for the visit
3. Schedule 15-30 minutes of time for a pre-audit interview (PI and key personnel)
4. Provide access to systems used to manage the project i.e. REDCap or Complion
5. Reserve a conference room or quiet area for the auditors to review the study records
6. Provide access to electronic or paper based study records:
   • Regulatory Binders with Study Staff and Delegation of Responsibility Logs and Protocol Training Documents included.
   • Study participant study information (source documents) including all the Informed Consent Forms and documentation of the informed consent process.
   • If there are any research documents or records (case report forms) stored on a computer, please note that we may need someone to assist with access to those documents.
   • Note that after our research compliance audit and in collaboration with the Post-Award Grants Accounting, Research Finance, and Investigational Drug Services (IDS), we will review the following, as applicable:  Clinical Trial Agreement, Coverage Analysis, and Investigational Pharmacy Records.
7. Plan for an optional brief phone call with UH Research Compliance staff to discuss any questions you might have about the audit visit
8. The documents that can be found here can also be used to prepare for an UH Research Compliance audit visit:
   • Internal QA Checklist-Participant
   • Internal QA Checklist-Regulatory

How to respond to UH Research Compliance audit findings?

A finding is non-compliance with the conduct or oversight of research that fails to comply with one or more of the following:

• Federal regulations
• The IRB approved protocol or investigational plan
• Policies - Institution, IRB, Sponsor, Funding agency
• Standard Operating Procedures (SOPs) - Institution or Department.

To respond to research compliance audit findings:  Get together as a study team and send one unified and complete response. If you do not understand a finding or disagree with a finding, set up a phone call with the auditor to discuss. Do not respond that you are going to do something in the future. Complete the task before you send your response. Unprofessionally written responses or to dismiss audit findings on your report that you may find irrelevant are not helpful. Do not recite regulations in a response our reports. Contact us for clarification. Check with your manager, the PI, or another member of the study team before you send your official response. We are here to help make sure that you are in compliance, and if there happens to be a research compliance finding, we will help steer you back onto the correct path.

Why does it feel like my department is being targeted for research inspections?

UH Research Compliance is focused on a variety of areas, including:

• Identifying and communicating best practices for the conduct of research
• Ensuring compliance with requirements and ethical standards
• Providing education and training for investigators and the overall research community
• Promoting and supporting research activities across the UH system
• Helping physicians and providers build their research programs
• Engaging physicians and providers who are new to research

Among our services, UH Research Compliance conducts routine and for-cause audits of active clinical research, provides connections to research education courses within a catalog offering over 50 courses covering a variety of research topics, and provides materials and support to aid in establishing research projects at main campus as well as in the community.

UH Research Compliance is committed to promoting standards of excellence in the conduct of clinical and translational research. Research compliance reviews and audits are unavoidable when you are engaged in research and our inspections are an institutional mandate with focus on decreasing risk to the institution and ensuring the safety of UH research patients.

I just took over a study from another coordinator. What do I need to know?

Questions to ask yourself as a new coordinator for a study are listed below. Once you have the answers to these questions or have completed the tasks listed, you should have all that you need to successfully take over:

• What are the specific departmental policies and procedures as it pertains to this research project?
• What will be the workflow or logistics for successful execution?
• What is the data management plan (storage location, who all has access, the systems utilized)
• Did I sign the delegation log?
• Have I had protocol training?
• Have I been trained on the Informed Consent Process and the eligibility criteria verification process?
• Where are the original consent documents and the regulatory binder?
• What is the communication plan (PI, PI secretary, study RN, RC, ancillary staff, etc.)?
• Who are my contacts or is there a communication tree?
• Where are the study locations?
• What is the current enrollment strategy or recruitment plan?
• What is the screening and enrollment status? 
• Do I know the Specimen labeling, collection, processing, handling, transport procedures?
• Do I know about the investigational product/device process and handling instructions?
• What is the AE, SAE, unanticipated problem, protocol deviation/violation reporting process?
• Where are the study supplies and how do I order these items?
• What equipment is used for this study and are the unit(s) calibrated, temperature controlled and monitored?
• Did I provide my signed and dated CV, CREC certificate, specialized certifications/licenses?
• Do I need to be Credentialed?
• Have I completed Investigator Training or attended Clinical Research Orientation?

The Sponsor on my study indicated that the study is a potential for an FDA Audit. Can I request an audit in advance of any Form FDA 482?

• Yes, you can request UH Research Compliance to assist you in preparing for an FDA Audit, but first we recommend that you review the SOP QA-501 - FDA Inspections.
• Next, we recommend that you perform an internal QA audit of your source documents, case report forms, and regulatory binder. The following compliance tools can assist you: Internal QA Checklist-Participant and Internal QA Checklist-Regulatory.
• Once you have completed those tasks, provide us with a few date options that work best with your schedule and we will coordinate with you the best time for us to come and review your records.
• After you have completed the above, we ask that if you have an industry-sponsored study, you notify your sponsor representative. They are also responsible for ensuring research projects are conducted appropriately.

When do I need a Form FDA 3454 vs Form FDA 3455?

Financial Disclosure by Clinical Investigators and 21CFR Part 54 in regards to:

FDA Form 3454: Certification: Financial Interests and Arrangements of Clinical Investigators and FDA Form 3455: Disclosure: Financial Interests and Arrangements of Clinical Investigators

What is a principal investigator (PI), and what are they responsible for in clinical research?

An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. The PI is ultimately responsible for the conduct of the study and for assuring compliance with IRB policies and procedures and with Federal regulations.

When study tasks are delegated by an investigator, the investigator is responsible for providing adequate supervision of those to whom tasks are delegated. 21 CFR 312 and 21 CFR 812.

What is the difference between essential documents, a regulatory binder, and a central binder?

Essential documents individually and collectively permit the evaluation of the conduct of a trial and the quality of data produced. Demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. SOP SS-301 - Maintenance of Research Regulatory Binders

Regulatory Binder Compilation of essential regulatory documents related to a study. All studies conducted at University Hospitals are required to keep a regulatory binder. It should tell the story of the study.

A Central Regulatory Binder is used for storing and organizing documents that apply to multiple studies. It allows for specific documents to be found easily. It may include some of the following items: all key personnel CVs, Clinical Licensures, certificates/documentation of professional certifications,  CREC certificates, facility lab manuals, operating guidelines, normal lab ranges, CLIA and CAP certificates, IRB Membership Lists or rosters, and training records.

What is the difference between a source document and a CRF (Case Report Form)?

Source Document - Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial). ICH GCP E6R2 1.52

Case Report Form - A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial. ICH GCP 1.51, 1.52, 4.9.1, 4.11.

When errors occur, what should I do?

To make corrections on paper documentation, make the change as follows: 

Draw one single horizontal line through the error, the correct value should be placed adjacent to it, the correction should be initialed and dated by the individual making the correction. Do NOT erase, scribble out, or use correction fluid or any other means which could obscure the original entry. If applicable, circle changes (in red).

Note that all research documents should be completed in indelible blue or black ink. No pencil or brightly colored pens as they can fade and become illegible over time. Any documents that are not completed in indelible ink should have certified copies made. Please see SC-410 Certified Copies of Research Regulatory Documents for details about how to make certified copies of research documents. All of these procedures ensure a complete audit trail exists for all data entries.

SOP SC-403 – Research Documentation

What kind of documentation is needed if something out of the ordinary occurs during the conduct of the study?

“If it isn’t documented, it didn’t happen”. The best practice is to document in a narrative notation:  What was done, why it was done, when it was done, how it was done, what was the outcome, and who did it. If there is conflicting documentation or discrepancies in source documents, clarification is required. Work with others to help ensure all discrepancies are resolved timely.

What is a Corrective Action and Preventative Action Plan (CAPA)?

CAPA is a quality process used in industry and clinical trials to address an existing noncompliance issues and prevent them from occurring again. There are seven basic steps to identifying and implementing a CAPA plan: identification, evaluation, investigation, analysis, action plan, implementation, and follow-up.

While the creation and follow through of a CAPA plan may seem like an onerous task that can get lost in the numerous items necessary to conduct a clinical trial, it is an extremely important aspect. A CAPA ensures the quality and safety of your research and the participants involved. In addition, it is a key area inspected by regulatory agencies, such as the FDA and Office for Human Research Protections (OHRP). Check out the Clinical Research Toolbox for a template and reference Clinical Research SOP QA-503 – Corrective & Preventative Action.

What is a SIV-Site Initiation Visit?

A collaboration meeting where all of the study team, including the CRO or sponsor, if applicable, will discuss and review the protocol including the time and events schedule, recruitment strategy, participant screening and enrollment, data management, investigational products or devices, specimen collection, and regulatory maintenance. SOP SS-303 – Site Initiation Visits

UH Research Compliance can provide tools and templates to get you started. Contact UHResearchCompliance@UHhospitals.org for assistance.

Who should be listed on the Delegation (of Authority) Log?

All key personnel who are considered study staff and who contribute to the scientific development or execution of a project in a substantive, measurable way must be listed on the delegation log. All staff who have been delegated by the PI any specific study tasks related to the protocol should be listed on the log and the names listed on this log must also match the names listed with the IRB. Tasks should be assigned within the Key Personnel’s scope of practice. In addition, they received training regarding their roles and responsibilities for the specific study protocol.

SOP’s GA-105 - Investigator Responsibility for Study Team Training and Documentation, SOP GA-104 – Scope of Practice, and QA-503 - Corrective and Preventative Action (CAPA) Plan

What are Good Documentation Practices?

Accurate and complete documentation is the cornerstone of Good Clinical Practice (GCP) and permits an observer to recreate a subject’s participation in a research study and to account for the use of any investigational products. Use ALCOA+C and remember: “If it’s not documented, it didn’t happen.”

SOP SC-403 – Research Documentation and ICH E6 (R2)

Who can sign off on participant eligibility?

The Principal Investigator (PI) is the person who is ultimately responsible for the conduct of a study and must ensure the eligibility criteria is assessed appropriately by study personnel. Research SOP GA 104 - Scope of Practice Appendix A states:final confirmation of participant eligibility and sign-off should be completed by a medically licensed principal investigator, MD, DO, PA, or CNP only as per state requirements. SOP GA-104 – Scope of Practice 

How long do I have to retain my research records?

See Records Retention Tip Sheet in the Clinical Research Toolbox - Regulatory Binder Kit.

All records associated with a human subjects research project are maintained and retained in accordance with federal and Ohio laws and regulations. Records should be secured and protected in a confidential manner. Requirements vary depending on the funding source and if conducted under FDA regulations. According to the UH IRB records should be kept a minimum of three (3) years following the end of the study. If applicable, projects not funded by Federal agency or do not involve FDA regulated articles, must be kept according to the Case Policy on Data Retention

Electronic records must be backed-up and records keep on site or offsite with vender must be approved. Keep human experimentation records for 30 years, IRB Documentation for 3 years, and research reports for 10 years. If documents are scanned in to the EMR, destroy originals within 30 days unless a legal hold exists on these documents. ICH GCP E6 4.9.5, 5.5.11, UH Policy GM-1 – Records Management.

What is an iron key (encrypted USB device) and how can I get one?

As of June 28, 2016, all users are required to use an encrypted USB device to save and copy data from a UH workstation to what is commonly known as jump or flash drives.  You may still access and view data on unapproved USB devices, but you will not be able to edit or save new data to the unapproved device. The use of secure, encrypted USB devices helps prevent the compromise of sensitive and protected information in the event the removable device is lost or stolen. A list of commonly ordered and approved USB devices is available on the UH Help Center website.

Research vs. Quality Improvement vs. Case report

Research is any systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge.

• Human subjects’ research obtains data through intervention or interaction with a living individual or obtains identifiable private information. (45 CFR 46) It can also involve providing results that are intended to be submitted to or held for inspection by the FDA as part of an application for research or marketing permit. It is excellent scientific research that advances the field, meets all federal regulations, and provides assurance that the rights, safety, and well-being of participants are protected.

Quality Improvement (QI) activities are generally limited to implementing an evidence-based practice to improve the quality of patient care, or collecting patient or provider data regarding for clinical, practical or administrative purposes.  In most cases, QI does not qualify as “human subject research” nor would it require IRB review or approval under the Federal Regulations.  In other cases quality improvement activities might be designed to accomplish a research purpose, as well as, the purpose of improving the quality of care and in these situations, prospective IRB approval is needed prior to engagement in any QI activity. Reference worksheet HRP-310 found in the UH IRB web portal SpartaIRB for further guidance.

Case Reports - If an investigator develops a case report that he/she wishes to present, publish, or use to fulfill the requirement for scholarly activity outside or UH and associated departments at Case Western Reserve University, this case report must be submitted to the UH IRB for review prior to dissemination (publication, presentation, etc.). Note that a case report that includes information from 3 or fewer patients generally does not meet the definition “research” (45 CFR 46.102[f] or 21 CFR 56.102[e]). Reference the HRP-503 NHR template found in the library of the UH IRB web portal named SpartaIRB.

*Excerpts from the UH IRB Manual, 21 CFR 312.53(a)