Guidance & Related FAQs
The OCR posts clinical research specific Guidance documents on this page, and related frequently asked questions (FAQs) from the clinical research community at Penn. Some of these questions and their appropriate answers have been populated below.
The OCR updates this list based on the volume of questions received on a particular topic. Keep checking back here for an updated list of FAQs.
The intent of the PSOM Guidance for Adverse Event (AE) Assessment is to provide early, mid and senior career investigators a roadmap for how to investigate, perform, and confirm AE assessments. We have seen an impressive reduction in the number of safety assessment non-compliance that correlates with an increased focus on education, supportive outreach, and enhancements to PennChart.
As research continues to evolve and transform to fit a highly remote climate and as space and storage continue to be constraints for research teams, we encourage all research teams to use electronic system for storage of research data including source documentation, electronic regulatory files and electronic data capture/ eCRFs.
Click to review Binder Guidance
Clinical Trial Guidance in the COVID19 Environment
Federal and local state mandates have significantly impacted how research is conducted throughout PSOM since the novel coronavirus outbreak in March of 2020. This FAQ (see link below) has been developed to incorporate various guidance that has circulated, as well as highlight some of the recommendations pertinent to research at Penn.
Please reference the following guidance from the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) communications as they have been subject to frequent updates during the pandemic:
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency: https://www.fda.gov/media/136238/download
- Statistical Considerations For Clinical Trials During the Covid-19 Public Health Emergency: https://www.fda.gov/media/139145/download
- Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biologics Product Manufacturing: https://www.fda.gov/media/139299/download
- OHRP Guidance on COVID-19: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html
Please refer to the attached FAQs developed by OCR for further assistance: Click HERE
Q: Does my study need to be registered on ClinicalTrials.gov?
Answer: There are a number of factors to consider when determining whether your study needs to be registered on ClinicalTrials.gov. The FDAA requirements for which studies must be registered can be found here http://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhichTrialsMustBeRegistered. It may also be important to consider requirements set forth by the International Committee of Medical Journal Editors (ICMJE).
Q: How do I obtain an account in order to register a study on ClinicalTrials.gov?
Answer: Email firstname.lastname@example.org in order to obtain a login under the UPenn institutional account
Guidance on use of Email and PHI while communicating with Patients
These guidance documents are important to the use of email and PHI in communication with patients and other Penn Medicine staff and employees. Penn Medicine’s Privacy Office and Information Security Office’s has issued guidance on avoiding and minimizing PHI in email communications. The Office of Clinical Research has collaborated with the Office of Audit Compliance and Privacy (OACP) to create a specific guidance on the use of email during the conduct of research studies and clinical trials.
An OCR communication to the clinical research staff community went out on February 11, 2020. Please contact email@example.com for situation specific questions or concerns.
Some commonly encountered questions are listed below:
- I have to request new MRNs for participants in my research study, that are not existing Penn Medicine patients. The request form needs PHI filled in. How do we communicate this information to the team that creates MRNs without sending them PHI?
Response- PHI should not included in the email beyond what is necessary. When technologically feasible, the email should be encrypted as described in the Guidance for Research document. In this situation, you would encrypt the MRN request form, found in Tools and Templates on the OCRwebsite, and email to the EMP IT group.
- Is it the expectation of the IRB/OCR that all current ICFs be modified to include the sample consent language informing subjects that we may communicate with them via email or are current open studies grandfathered in?
Response- No, it is not expected that all consent forms be updated. This is only recommended language that be included if the expectation is that communication will take place throughout the trial via email and PHI will be shared with the patients through email. The language can be modified to fit the study.
Q: Our team has a Spanish speaking patient for a study; does the short form need to be IRB approved? How can I contact Penn’s translator resources?
Answer: Please refer to the IRB website for complete information. Generally, you may be able to use an IRB approved Spanish short form to consent a Spanish-speaking patient. You will need to get IRB approval to use the Spanish short form. Sometimes, this can be an expedited approval; call the IRB for detailed instructions on how they want you to enter this request.
You will need a translator/witness who is fluent in both English and Spanish. You can either use a family member of the research subject if they are in fact fluent in both languages, or a medical team member who is fluent in Spanish. The other option is to call hospital translation services and arrange for them to be at the appointment. Penn Language Link can be reached at firstname.lastname@example.org
Q: Our study team has received a continuing review approval from the IRB and we have a newly stamped consent form. There have been no changes to it. Do we need to reconsent subjects?
Answer: Subjects only need to be re-consented when there have been changes to the consent form that warrant a reconsent i.e. changes in procedures or subject safety information, in this case the answer would be “no”. Caveat: there are some places at Penn - notably CHPS, unless they changed their procedures - that require a currently stamped, signed consent form.
Institutional Review Board
Q: We have a study that involves retrospective chart review and does not need to use UPHS for patient care services, should this be indicated as yes in the IRB's HSERA application?
Answer: Indicate “No” in application. If you are just reviewing data from EPIC and your subjects are not taking any additional testing or procedures then UPHS services are not being used.
Q: We have received a continuing review approval from the IRB and have a newly stamped consent form. There have been no changes to it. Do we need to reconsent subjects?
Answer: No. Subjects only need to be reconsented when there have been changes to the form that warrant a reconsent.
Q: When can I request a waiver of documentation to the informed consent process?
Answer: When there is a study reviewing retrospective Also, a study with minimal risk to patients and no patient procedures may be eligible. The IRB will make the final determination that a waiver of consent is appropriate.
Investigational New Drug
Q: After our study was submitted to the IRB, we have been asked to consider whether the study needs to be an IND Sponsored study? Who can help us determine this?
Answer: To determine whether your study needs to be under an IND contact the IND-IDE unit within the Office of Clinical Research. Email email@example.com to contact the IND-DE unit.
List of Research Resources
List of Research Resources: Click here
Q: What PennChart trainings are required for a new Clinical Research Coordinators (CRC), in order to get access?
Answer: Please contact OCR to assist you in determining the correct trainings.
Q: How do I register a healthy subject in PennChart?
Answer: This is typically done for subjects or patients that do not have a pre-existing MRN in our PennChart system. In order to request a patient MRN, please fill out this form and email the form to the EMPI (Epic) at EMPITeam@uphs.upenn.edu.
Penn Data Store to Assist in Conducting Research at Penn
Q: How do I request a report for the Penn Data Store (PDS)?
Answer: As a Penn affiliate, you can request a data report by visiting the Penn Medicine Data Analytic Center page: http://www.med.upenn.edu/dac/. Click on “Request a Report” and follow the steps listed.
Q: Are summer staff members that have a UPHS/Penn IDs and proper training, considered Penn affiliates?
Answer: Yes, summer staff that have a valid Penn ID and have received proper training, which can include CITI training and HIPAA training, are considered Penn affiliates. Check with the IRB (firstname.lastname@example.org / 215-573-2540) to ensure you have required or appropriate training. Affiliations should not be granted to non-affiliates simply for the purpose of granting access to the electronic medical record/electronic data resources.
Q: Is Children’s Hospital Of Philadelphia (CHOP) part of a Penn Covered entity?
Answer: No, CHOP is not a part of Penn’s covered entity and therefore CHOP employees do not have direct access to the Penn Data Store. If you are a CHOP employee and need information from the PDS, you may have to consider working with a Penn collaborator.
Q: The CHOP Non-Traditional Personnel (NTP) research document: is there a similar process defined at Penn?
Answer: No, the NTP research document can be found on the Society for Clinical Research Coordination and Management (SCRCM) website. It is a document that was prepared by the SCRCM -in collaboration with CHOP personnel. It defines the on-boarding process for Non-traditional personnel at CHOP. There are on-boarding tools available on the SCRCM website by choosing the On Board Tools option from the SCRCM home page menu.
Q: Is this data you receive from PDS reports considered source documentation?
Answer: The report is not considered source documentation if the information is being used as information preparatory to research. This type of report is called PennSeek Preparatory Research. This type of report provides a count of potential subjects that may be eligible to participate in a proposed study. Access to this type of report does not require IRB approval. Although it provides access to all subjects with HUP MRNs defines, PHI data are redacted, making it de-identified, and export functionality is restricted.
A more detailed report can be requested from the PDS which is called PennSeek Recruitment. This report is designed to allow both refinement of search criteria and immediate review of identified cohort data. It is ideal for narrowing your cohort, requesting research study IDs, and accessing subject data across categories for research purposes. PennSeek Recruitment provides access to all subjects with HUP MRNs defined, and requires IRB approval. If PennSeek Recruitment is used and a subject enrolls in the study, this information becomes part of the source documentation.
The last type of report, PennSeek Research, is intended for review of specific patient cohorts. It provides the ability to export any and all data related to predefined cohorts for additional analysis or pre-publication de-identification tasks, and requires IRB approval. PennSeek research only allows access to subject cohorts defined by research study IDs. For more information refer to the PennSeek website: http://www.med.upenn.edu/dac/pennseek.html.
Q: For a study that is already IRB approved and has been slowly enrolling but needs an increase in the enrollment, can a site contact PDS now to get information about potentially eligible subjects?
Answer: Yes, you can start to use the PDS after a study is approved but you must first submit a modification to the IRB that contains an updated recruitment plan stating that PDS will now be used. Include the method of how the information gained from PDS will then be used at your site (e.g., mailings, phone calls, etc.)
Q: Is there a fee to use the Data Analytics Center’s products and services (this includes services such as Penn Data Store, Penn Seek, Cohort Explorer, Requesting a Report, Accessing business Objects, scheduling office hours)?
Answer: No, there is no fee to use the Data Analytics Center’s products and services. Please keep in mind that we are unable to perform rich statistical analysis and complex computations. If you need such work and have funding available, please visit the Biostatistics Analysis Center: http://www.med.upenn.edu/cceb/services/becc/bac/index.shtml
Q: What kind of financial information can a site get from the Data Analytics Center?
Answer: Financial information (such as which benefit plan, primary payer, financial class, charges, payments, adjustments, reimbursements) can be requested in a report from the Data Analytics Center. For more information on the financial data available to be requested from the Data Analytics Center, please refer to the Data Analytics Center website and review the Data Warehousing >> HPM section: http://www.med.upenn.edu/dac/hpm.html
Q: Can a cumulative summary of all financial charges for a particular subject be found?
Answer: Yes. You can request a data report of financial information for a particular subject for a specific time period (i.e. 3 months).
Q: How can I get access to the PennOmics Cohort Explorer to run reports about potential subject populations for a particular study?
Answer: The Cohort Explorer is self–service tool which grants researchers direct access to a fully de–identified dataset compiled from Penn's subject population and complimented by genomic data from clinical labs and contributing researchers throughout the University and health system. To learn more and request access, please visit the Data Analytics Center’s website and review the Data Warehousing >> PennOmics section: http://www.med.upenn.edu/dac/pennomics-access.html
Q: Who can I contact with questions about a data use agreement?
Answer: You can contact Megan Kasimatis Singleton or Patrick Stanko at the IRB for questions about a data use agreement.
Megan Kasimatis Singleton, Associate Director, Human Research Protections, email@example.com
Patrick Stanko, IRB Assistant Director, firstname.lastname@example.org
If you are sharing data with an external entity, (either providing data or receiving data), requests for a data use agreement should be submitted through the Non-Monetary Agreement section of Penn’s Office of Research Services website. Study teams should use this mechanism to secure department or center and school approval of an agreement that does not bring funding into Penn.
Q: Can a data use agreement be set up for multiple studies that use the same data?
Answer: Yes, it is possible to set up a data use agreement to cover multiple studies. You will have to stipulate which studies this data use agreement will cover. You can add new studies to the data use agreement as needed by filing an addendum to the agreement.
Q: Is there an “opt out” option for Penn subjects that they can choose to say they don’t want to be contacted for research?
Answer: No, currently the only option is a “do not solicit” option which is intended more for individuals who wish to opt-out of marketing activities. This is not intended to indicate the desire not to be contacted for research.
Q: Is anyone tracking who is contacted and when?
Answer: No, there is not currently a mechanism in place to systematically track which subjects have been contacted or who has contacted them.
Penn Medicine Guidance for Text Messaging and Research
The purpose of this document is to provide guidance to researchers considering using texting as a form of communication with study participants. Please note texting may raise privacy concerns on behalf of recipients, especially before subjects have signed consent.
Q: Does OCR offer REDCap Workshops? Are there online videos resources for REDCap ?
Answer: The Office of Clinical Research (OCR) attempts to offer training on REDCap on a regular basis. These workshops however fill up very quickly. Penn and REDCap have video resources that one can use to learn basics of REDCap .
REDCap training videos: https://redcap.med.upenn.edu/index.php?action=training
For additional assistance, contact the REDCap help email: email@example.com.
Remote Consent Procedures
Guidance on Remote Consent Procedures
In the event of a health pandemic (i.e. COVID-19 declared on March 11, 2020) documenting consent from subjects utilizing methods other than pen and paper will be permitted. The IRB has collaborated with the PSOM Office of Clinical Research to develop a guidance on Remote Consent Procedures during the current pandemic. This document contains guidance on documentation and consent discussions.
All other schools: Remote Consent Guidance for non-Penn Medicine and non-Penn Dental Schools
Updates to Forms and Guidance
New guidance has been posted to assist researchers utilizing devices in clinical research. Please see: https://irb.upenn.edu/mission-institutional-review-board-irb/guidance/types-research for more information.
Sponsor Support related FAQs
Q. If I’m using an approved drug (or device); do I need an IND (or IDE)?
A. If the use of the drug or device product on the protocol is per the approved product labelling, the study may be exempt from IND (or IDE) requirements. However, we recommend that you complete an exemption form for an official exemption determination by the Office of Clinical Research. For CTAs (clinical trials in foreign countries), please reach out directly to the SSU for specific guidance.
Q. How do I obtain a US device study risk determination?
A. The Sponsor or Sponsor-Investigator of the study should make and document an initial risk determination. The risk determination should take into account the use of the device on the protocol. This risk determination should be presented to the IRB. The IRB also needs to make a risk determination. If the IRB deems the study to be non-significant risk, the Sponsor or Sponsor-Investigator will hold an abbreviated IDE. If the IRB determines the study to be significant risk, the investigator must submit an IDE application to the FDA.
Q. I’m using both a drug and a device on my study and I do not qualify for exemption. Do I need both an IND and an IDE?
A. No. Whether you need an IND or an IDE depends on which product is the primary mode of action in the study. If an investigational drug product is the primary mode of action, you may need an IND. If an investigational device product is the primary mode of action, you may need an IDE. Product accountability and assessment of safety events should still occur for secondary (and other) investigational products.
Q. Do I need an investigator’s brochure and what should it include?
A. An investigator’s brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) relevant to the IND/IDE/CTA. If an IND/IDE/CTA includes more than one investigational product, clinical and nonclinical data on each investigational product should be included. A medically qualified person should generally contribute to the authoring of an IB. An IB template is available here.
Sponsor-Investigator Drug Trials
One US site
IB not needed
Multiple US sites
IB is needed
Foreign drug trial
IB is likely needed (depending on Health Authority)
Sponsor-Investigator Device Trials
IDE with no secondary drug products
IB not needed; Investigational Plan required
IDE with secondary drug products
IB is needed; Investigational Plan required
Foreign device trial
IB likely needed (depending on Health Authority)
If the investigational product is marketed and its pharmacology in your patient population is widely understood by medical practitioners, an extensive IB may not be necessary. In cases where preparation of a formal IB is impractical, the sponsor-investigator should provide an expanded background information section in the protocol that contains at minimum the information described in FDAs Guidance for Industry E6 Good Clinical Practice Consolidated Guidance.
Q. When should I submit to the IRB (or ethics committee) if I am submitting and IND/IDE/CTA application to the FDA/Health Authority?
A. We recommend that you submit IRB (or ethics committee) applications and IND/IDE/CTA applications concurrently.
Q. Who should be listed in Field 6 (Sub-investigators) on a 1572 (or Investigator Agreement)?
A. Any investigative team member who makes a direct and significant contribution to the data should be listed on the 1572 in Field 6 (or sign an investigator agreement for IDE studies). In most cases, hospital staff who provide ancillary or intermittent care as part of their normal duties, do not need to be listed.
Q. When should the PI sign the 1572 (or Investigator Agreement)?
A. The investigator’s signature constitutes the investigator’s written commitment to abide by FDA (or Health Authority) regulations in the conduct of the clinical investigations. The investigator should sign the form only after being given enough information to be informed about the clinical investigation and to understand the commitments (described in 1572 Field 9). Having enough information about the study means that the investigator and all subinvestigators have received copies of, have read, and understand the protocol and investigator’s brochure (if applicable), and are familiar with the regulations governing the conduct of clinical studies. Typically, the 1572 (or IA) is signed after the SIV. However, if it is clear that members of the research team still have questions about the study, the 1572 (or IA) should not be signed until these questions are resolved.
Q. What is a Clinical Hold?
A. A clinical hold is an order issued by FDA (or Health Authority) to the sponsor to delay the commencement of a proposed clinical investigation OR to suspend an ongoing investigation. The clinical hold order may apply to one or more of the protocols covered by an IND.
Q. I submitted an IDE application and 30 days have passed. Can I start my study?
No. Unlike an IND, IDE’s require approval by the FDA before the study can commence.
Q. We conducted a Site Initiation Visit (SIV). Can I now start my study?
Before a study can start, the Sponsor needs to ensure:
- All sponsor and investigator staff
- Are aware of their delegated tasks
- Have the knowledge and training to complete the delegated tasks appropriately
- Have current version of all core study documents
- All required approvals (FDA, IRB, other institutional approvals, etc.) are obtained
- DSMB (if applicable) has reviewed and approve core documents (protocol, IB, DSMB charter, ICF, DSMP, etc.)
- All vendors/staff qualified
Q. What is a vendor, and why do I need to qualify vendors?
A. A vendor is person or organization contracted to be involved in a clinical trial. A vendor can be a company, person, organization, or institution. Vendors include laboratories, manufacturers, principal or sub-investigators, CROs, etc.
Qualification of a vendor documents that the individual/company/organization/institution is capable of performing their delegated responsibilities. Qualification consists of ensuring that the vendor has the appropriate training, education, experience, and resources to complete the required task(s).
Q. Does my trial need a Data Safety Monitoring Board (DSMB)?
A. IND/IDE/foreign clinical trials are not required to be overseen by a DSMB. However, the Sponsor has the responsibility to assess whether a DSMB is needed and document that decision in the Sponsor records.
Q. How do I identify Sponsor team members?
A. The Sponsor team has oversight of the IND/IDE/CTA activities. This team ensures GCP, GVP, GMP, and GLP activities are carried out as per the regulations and guidances. Ensure that each team member has the appropriate training, education, experience, and resources to complete the required task(s). Sponsor team members’ qualifications should be documented in the sponsor files (trial master file).
Q. What does a monitor do?
A. A monitor is a member of the Sponsor team that performs quality control activities that ensure the ethical conduct, proper collection and documentation of study results, appropriate records of study procedures and subject interactions, and compliance with the approved protocol.
Q. What is a Clinical Study Report?
A. A clinical study report (CSR) is a lengthy, integrated, scientific report that is completed after a clinical protocol is completed and the data is locked. The report details the methods and safety/efficacy results. It incorporates tables and figures and includes appendices containing the protocol, sample case report forms, investigator-related information, information related to the test drugs/investigational products including active control/comparators, technical statistical documentation, related publications, patient data listings, and technical statistical details such as derivations, computations, analyses, and computer output.
Q: Our research study at Penn collaborates with CHOP, we are compensating participants in the form of an Amazon gift card. Do we need to collect SSN with a W9?
Answer: For CHOP, if payment is in the form of petty cash a W9 is not needed for each participant. For UPenn, refer to the SOP for human subject payment at Penn, refer to pages 13 and 14. See the document on this link: http://www.med.upenn.edu/policy/user_documents/RefGuide_humansubject_0408.pdf.
You need to fill out what is called a form C2 or a human subject voucher. This will ask only for the last 4 digits of the ssn, not all of it. This should be stored in a confidential place in your regulatory binder.
Q: What is the process when participants that make over $600 in a calendar year?
Answer: You need information for 1099“s. Collect W9 for participants who will meet the minimum of $600. Contact Office of the Comptroller for any questions at 215-898-2626
Q: What is the Greenphire ClinCard?
Answer: This reloadable prepaid card is available as a payment option to compensate or reimburse human subjects for participation in clinical research. There is a link to a demo video on the Office of the Comptrollers page.
Q: Is there a daily maximum that you can put on the ClinCard?
Answer: The maximum a card can hold at any given time is $10,000. You can load predetermined amounts on the card. If it is less than $100, it is taken care of in the Office of the Comptroller. However, if you are loading more than $100, it must be approved.
Q: What happens if the card is lost?
Answer: When you register into the clincard system there will be a tab to assign clincard. Once this card is assigned, the tab will change to “re-assign” so that if a patient loses the card, you can go into their profile and assign them a new card. The old card will be deactivated and funds will be transferred to new card.
Q: How long does Greenphire keep patient information?
Answer: Seven years. After that, it will be purged and provided to Penn in a secure manner.
Q: What if a patient forgets their PIN or the card is stolen?
Answer: They can call customer service to speak with a live agent or go to myclincard.com. They can write a general email to support team, check their account balance or transaction history. If it stolen, they can call to cancel the card. Every card is covered under MasterCard zero liability policy. If there are fraudulent charges, this can be addressed with MasterCard and will be investigated. It will be a $7 deficit off of their card if Greenphire sends or will be free if Penn provides a new card it is free to the subject but it comes at a hard cost to Penn for providing card to Penn.
Telemedicine Platforms and Research – Guidance and Best Practices for Zoom, Blue Jeans and Microsoft Teams
Penn Medicine (UPHS And PSOM) Guidance Video Conference Platforms and HIPAA Protected Health Information (“PHI”)
Penn Medicine (UPHS And PSOM) Guidance Video Conference Platforms and HIPAA Protected Health Information (“PHI”). For more information about specifically using telemedicine in research that overlaps with standard of care, continuity of care or any research that involves billing to insurance or mixed billing please refer to the following document/ Clinical Research Connected Health Telemedicine Guidance.
How to tell if you are using Penn Medicine or University Meeting Services
How to configure services for privacy and compliance
Use of Electronic Signatures in Research and Title 21 CFR Part 11 Compliance
This document explains several options for the use of electronic signatures in research at Penn Medicine and the relationship to Title 21 CFR Part 11 FDA regulation. This document’s audience is research and clinical staff engaged in human subject research who may be requested to use electronic signatures by their sponsors. It covers certain uses of e-signatures for research trial related documents and systems, however it does not cover the use of electronic signatures related to contracting, business administration, grant submission (PennERA), or the effort reporting system (ERS).
Vendormate is a 3rd party vendor Penn Medicine uses to back ground check pharmaceutical company representatives, and their immunization status. This to mostly protect patients especially immunocompromised patients in clinic spaces. Registration in Vendormate costs about $250 per year to register. This requires yearly renewal by the company, and updates of the representatives immunization records. The cost for this is included in the budget template by OCR Finance so teams can incorporate it before they negotiate with the pharmaceutical sponsor. The pharmaceutical representative category is also extended to CRO/ sponsor monitors that will be in clinic spaces.
The link below is a brief step by step of how a Pharmaceutical vendor rep registers on the platform, and the screen shot below is that of the main website, and video tutorial that the vendor can accesses at: https://registersupplier.ghx.com/reg/network/vendor/
Step-by-Step Link: https://www.med.upenn.edu/ocrobjects/attach/2020-06_Vendormate.pdf
The policy that refers to Vendormate and pharmaceutical representatives resides on the UPHS Intranet at (Document is password protected. Copy-paste link in browser if clicking does not open it): https://pennmedaccess.uphs.upenn.edu/f5-w-687474703a2f2f75706873786e65742e757068732e7570656e6e2e656475$$/pahhome/pahpolicies/M15.pdf
Contact for Vendormate at Penn:
Director, Materials Management
Hospital of the University of Pa
Email: Robert.Fisher@uphs.upenn.edu/ Robert.Fisher@pennmedicine.upenn.edu
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