September 1, 2020
COVID-19 Updates for Clinical Research
June 8, 2020
To: Provost’s Council on ResearchFrom: Dawn Bonnell, Vice Provost for ResearchDate: June 5, 2020
RE: Research Resumption – June 8 Start Date
As you know, the original date of Research Resumption was delayed due to circumstances inPhiladelphia. Monday June 8, 2020 has been designated as the date research may begin toramp up. However, research cannot be initiated unless all safety measures are in place. In lightof recent access issues to campus, several units are delaying the onset in order to be prepared.Please keep housekeeping informed of your plans so that they can properly support yourbuildings.The significant activity expected in the city this coming weekend could cause disruptions thatwould preclude opening on Monday. Please refer to Penn Alert notices for University closurenotices, which supersede the research specific guidelines.
IMPORTANT MESSAGE: Phased return to clinical research activities
May 11, 2020
Dear Clinical Research Staff,
Please read the attached document that outlines the considerations for a phased return to clinical research. While we wait for direction on the timing of when this may occur from the State, City, University and PSOM, I am sharing this plan with you so that you can start to plan with your teams. This may also give you an opportunity to ask questions in advance.
As clinical care activities begin to increase, there is a natural inclination to want to reactivate suspended clinical research activities. Recognizing that, please remember that until the “shelter in place” restrictions are reduced, only the following types of clinical research activity are permissible at this time.
- Essential Clinical Trials include the following
- New and existing clinical trials that hold the clear prospect of benefit for patients with life threatening or serious conditions
- In-person study visits required to assess safety of patients who were enrolled in clinical trials prior to the pandemic
- New and existing clinical trials where enrollment into the trial is the only available option for the patient
- COVID Clinical Research
- As clinical service lines begin the “resurgence” to clinical practice; new and existing clinical trials and non-interventional clinical research where the research activities that must occur on site can occur during inpatient stays and during patients’ already scheduled clinical visits and those same research activities can be executed; without requiring that clinical research support staff return to campus. PIs must confirm that imaging, IDS, CHPS, CVPF and all other research specific services have essential staff on site and are available to execute the trial.
- Research that can be conducted remotely should continue to be conducted remotely with all staff working remotely. This includes:
- Trials where in person visits can be eliminated or conducted remotely via telemedicine and investigational meds can be delivered to the participants’ home
- Non interventional research where research participants do not need to come on campus, research staff can effectively execute the research activities remotely and direct contact with participants is not required.
Please remember: PIs and CRCs conducting ‘Essential Clinical Trials’ and ‘COVID Research’ work (# 1 and 2 above) are considered essential employees and are required to work on-site and adhere to all requirements to reduce likelihood of infection of staff and research participants. Research staff involved in # 3 above, monitoring, auditing, training, SIVs, research systems support, financial management, contracting, and regulatory support activities are not permitted to return to campus at this time. Clinical research participants are not permitted on campus unless they are a participant in an approved essential trial, a COVID research study or they are on campus for clinical care reasons as in-patients or outpatients.
If you have questions related to oncology research activities please work with Bob Vonderheide. Otherwise feel free to route your questions to me.
Emma A. Meagher, MDProfessor, Medicine and PharmacologyVice Dean & Chief Clinical Research Officer, Perelman School of Medicine
ClinicalTrials.gov does not offer a “pre-review” of the study record as part of our regular QC review process. After record Release, registration record reviews take 2-5 business days and review of records with results take up to 30 days if the study appears to be an applicable clinical trial or is NIH-funded. Other types of study records with results will take longer.
Instead of “pre-review”, we offer targeted assistance to help investigators with specific issues and one-on-one assistance for investigators new to submitting results information. For example, if an investigator would like a brief overview of the required information before beginning data entry, assistance with learning how to enter results information, or would like to discuss strategies for entering a complex study design or unique outcome measure or analysis, then we are happy to provide email assistance or schedule a teleconference. In addition, we can also provide assistance in addressing QC Review Comments when there are questions. Requests for email assistance or for a teleconference should be submitted to email@example.com.
To understand the criteria that ClinicalTrials.gov staff use for QC review, we recommend consulting the review criteria for both registration and results information (included below). These are intended to assist you with improving data quality and avoiding major issues.
- ClinicalTrials.gov Protocol Review Criteria (PDF): Describes review criteria for study records submitted to the registry (June 2018)
- ClinicalTrials.gov Results Review Criteria (PDF): Describes review criteria for each scientific module in the results section of the study record submitted to the results database (June 2018)
- PSOM Research Consent Guidance Memo
- Additional Guidance Regarding Consenting Subjects in Interventional Studies
Clinical Research Annual Recognition of Excellence Awards
The Clinical Research Coordinator Annual Recognition of Excellence (CARE) award is an annual recognition event hosted by the Penn Society of Clinical Research Coordination and Management (SCRCM) and the Office of Clinical Research (OCR). This event is to celebrate our clinical research staff at Penn and honor members of our research community who best exemplifies excellence in the knowledge, skills and values of the clinical research profession.
When: Thursday, June 13th 2019 11:45 AM to 2:00 PMWhere: Biomedical Research Building (BRB) Auditorium
Clinical Research Interview " Managing Endometriosis Leading to Infertility"
Date: April 10th 2019Time: 4:00PM — 5:00PM
We speak with Dr Suneeta Senapati, assistant professor of Obstetrics and Gynecology at the Hospital of the University of Pennsylvania. Click HERE to RSVP to this upcoming talk.
Discussion: Background: Endometriosis is a debilitating condition in which the tissues lining the inside of the uterus starts to grow on other organs outside of the uterus. The relationship between endometriosis and infertility has been debated for many years. About 25% to 50% of infertile women have endometriosis, and 30% to 50% of women with endometriosis are infertile. Research shows that the natural capability to produce offspring (fecundity) is lower in women with endometriosis as compared to women without. In addition, endometriosis is associated with a lower live birth rate. We are talking to Dr Suneeta Senapati of University of Pennsylvania about the impact of endometriosis on fertility and how it can be managed better to reduce the burden of infertility.
PA Supreme Court Decision Impacting Consent - Additional Guidance for Clinical Research from OCR and IRB
Since the July 21, 2017 email to the Penn Research Community regarding the Pennsylvania Supreme Court decision impacting consent, including informed consent in research, OCR and the IRB have received numerous requests for more detailed guidance. The purpose of the documents linked below are to provide more detailed implementation guidance to the research community regarding obtaining informed consent in clinical research at the Perelman School of Medicine.
- Guidance Document around Consenting Clinical Research Subjects in Interventional Trials from the IRB and OCR
- Additional Guidance in the form of an FAQ document based on research use cases
Message to NIH grant applicants/awardees, contractors, researchers and research administrators:
If you are conducting NIH funded research that involves human subjects, or considering applying to NIH for support of such research, we want to call your attention to important changes that may affect you. Click to go to the original announcement of the NIHs new Clinical Trial Requirements for NIH Grantees and Contractors. Your attention to detail will be critical to ensuring successful funding of your clinical trial awards.
Note about GCP Training: The Office of Clinical Research (OCR) offers an Onboarding curriculum that provides comprehensive GCP training. Researchers who have already completed GCP training still have the option of accessing the GCP training tracks we offer:
- ACRP Good Clinical Practice Training
- Experienced for Principal Investigators
- Experienced for Clinical Research Coordinators
Blinded Studies and MPM documents now posted on OCR website
If you are working on a research study that has test results in PennChart that need to be blinded from the patient (the patient is not to see the results), you are now able to suppress the results from being sent automatically to the patient from PennChart to their myPennMedicine account, thus aiding in maintaining the blind.
2016 IRB Continuing Review Form – Feedback Survey
On March 1, 2016 the IRB released the pilot version of the new submission form for Continuing
Review. The Continuing Review submission form became required as of June 1, 2016. In July
2016 the HSERA continuing review application was revised to remove redundant questions in
support of using the new form.
Memo: Click for full announcement
2017 Clinical Research Annual Recognition Event
The 2017 C.A.R.E Award starts March 20th. For more details: Click Here
New Penn Medicine Policy for Clinical Research- philanthropic funding in advancing clinical research efforts
This policy is in effect immediately and will be administered by Penn Medicine's Institutional Review Board (IRB) in consultation with the offices of Development and General Counsel.
As a leading health care institution, we remain committed to the equitable selection of research subjects and the need to mitigate any perceived or real conflicts of interest associated with the inclusion of subjects into research conducted here. The IRB and Development teams, have developed a short training module for researchers, medical professionals, and development staff detailing this policy and the important roles you all play in ensuring our collective efforts don't compromise the integrity of the scientific process.
We encourage you to share this new donor policy module link with any of your colleagues directly involved in the planning and implementation of clinical research efforts at Penn Medicine. Please contact either of us if you have any questions about the policy. Thank you for your time and attention to this important matter.
Tracy A. Ziolek
Director, Human Research Protections Program
Paul B. Mischler
Deputy Chief Advancement Officer & Chief Operating Officer
Penn Medicine Development and Alumni Relations
The Office of Clinical Research and PennChart Research recorded a “demo” of the functionalities for PennChart/ EPIC Research that will go live at PAH and CCH on October 22, 2016 and HUP, PPMC and HCHS on March 4, 2017 . This Research Demo of PennChart is not for training purposes and cannot be used as credit towards PennChart Training.
Sponsors of INDs, IDEs, or Comparable International Regulatory Filings
As of July 2016, all Perelman School of Medicine (PSOM) Sponsors of INDs, IDEs, or Comparable International Regulatory Filings are required to complete Sponsor Registration. In addition, Sponsors are required to complete Sponsor training. Sponsors outside of PSOM are encouraged to complete Sponsor Registration and Sponsor training as well. For more information, please click here to view Sponsor SOP 006.
Please register as a Sponsor here: http://tinyurl.com/z7frse6
Documentation from OCR confirming Sponsor Training Completion should be uploaded by the PI team to HS-ERA. IRB approval may be delayed in the absence of training documentation.
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