Office of Clinical Research

As we close 2022, we would like to congratulate our three CARE award winners,  Kelsey Moulton, Vanessa Madden and Elizabeth Moore; on the recognition of their dedication to the clinical research profession at Penn Medicine. Many others were nominated for these awards and even more are dedicating their time and effort driving our clinical research mission. I would like to take this time to thank you all for your hard work and hope you have a wonderful holiday break!

Close

Special thanks to all our nominees, nominators and guests at the C.A.R.E Awards ceremony on Nov. 3.

Introducing this year’s award winners who best exemplify excellence in the clinical research profession.

---

	Rising Star Award Kelsey Moulton, Department of Neurology
	Leading Edge Award Vanessa Madden, Department of Medicine
	Lifetime Achievement Award Elizabeth Moore, Department of Emergency Medicine

If you missed the ceremony, head over to the C.A.R.E. Awards website.

Close

Starting January 25, 2023, all grant applications or renewals that generate Scientific Data must include a detailed plan for managing and sharing data through the entire funded period with plans for data dissemination.

You must provide this information in a Data Management and Sharing Plan (DMSP). In addition, once the award is made and plan approved, compliance with the DMSP will be a determining condition of the work, meaning it can impact future funding decisions.

Guidance on selecting a registry for sharing- https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientific-data/selecting-a-data-repository

Penn resources and guidance for DMSPs https://guides.library.upenn.edu/NIH

For now , questions can be directed to the OCR inbox (psom-ocr@pobox.upenn.edu)

Close

iConnect v.6 is set to go live in 2023. New features and improvements include:

• 9000+ volunteers; 3400 healthy controls
• Customizable study websites
• Multi-language translation
• In-clinic patient screener
• Referral messaging
• Additional pre-screener options

Close

January 2023, Penn will migrate SiteVault Enterprise (SVE). Penn Medicine offers SiteVault Enterprise (SVE), for managing the investigator site file or electronic regulatory binder. Visit the OCR website for more information.

Close

Starting March 6, 2023, the University will move from Knowledge Link to Workday as it’s Learning Management System of choice. All OCR clinical research trainings will be administered, tracked and reported through Workday.
Learn More About Workday

Close

electronic SUbmissions to CDER – NextGen Portal

Introduction

The FDA has three Offices in charge of the evaluation of human medicinal products. The FDA’s Center for Drug Evaluation and Research (CDER) is the Office within the FDA in charge of the evaluation of drugs. The Center for Biologic Evaluation and Research (CBER) evaluates biologics, and the Center for Devices and Radiological Health (CDRH).

Electronic submissions to the CDER are provided in two different formats: eCTD and alternate format. Although the majority of electronic submissions to the FDA are for commercial products and are required to be in eCTD format, some submissions are exempt from the eCTD requirement. Research (i.e., noncommercial) INDs (the ones typically submitted by Academia Sponsor Investigator) are exempt from the eCTD requirement and may be submitted to the FDA in an alternate electronic format.

Electronic submissions are easier to produce, faster to submit and more cost-effective because materials and shipping costs have been eliminated!

The CDER encourages Sponsor-Investigators’ submissions to be made electronically and provides an alternate electronic submission pathway to sponsors or applicants: CDER NextGen Portal. This conduit to CDER provides the following benefits:

• Efficiency: Eliminate the time, hassle and cost of printing and mailing/shipping paper or physical media. Simply submit online.
• Timeliness: No more waiting for your submission to be delivered.
• Ease of Use: Requesting via the Portal is easy, and all information regarding your requests is stored in one place.
• Automated confirmation: After initiating a request, and you receive an automated confirmation of your transaction.
• Historical record: All transactions may be viewed at any time.

Type of Electronic Submission	Submission Conduit	Comments
Electronic alternate format	CDER NextGen Portal	Submissions to CDER only No specific submission format required Establishing your account is an easier and faster process This is the submission method OCR recommends to Sponsor-Investigators filing to CDER
Formal eCTD	ESG	Submissions must be in eCTD format Establishing your ESG account is a more and preparing the submission is a more complex process Once a submission is made via the ESG, all subsequent submissions are made via the ESG
*CD/DVD (6 disks max.) External hard drive	US Mail, shipping, courier	A printed copy of the cover letter should be included with electronic media submissions
*Paper	US Mail, shipping, courier	Each submission must be provided in triplicate (original plus two copies). Follow paper-submission requirements: Page size, margin sizes, 3-hole punched, etc.
* Although physical media and paper submissions are still accepted by CDER, their use is discouraged. Also note that these submissions take longer to receive a response/acknowledgement because CDER Central Document Room personnel must manually process the submission.

CDER NextGen Portal

Apply for your CDER NextGen Portal (“Portal”) account so that you may interact with CDER and complete the steps necessary to submit your Research IND application. These steps may be taken by the sponsor directly or by someone assisting the sponsor:

1. Use the Portal to request an IND number.
2. Once you have your IND number, use the Research IND (RIND) Application Builder to build your Original IND Application submission. The RIND tool helps you to compile your submission by providing prompts to enter information and upload documents.
3. Generate the Form FDA 1571 for the Sponsor to sign. This form will be generated with information that you entered via the RIND-tool prompts, and it will be directly emailed to the Sponsor. Once the Sponsor signs the form, you will be notified via email, and you can continue with the submission.
4. Download a copy of the submission before submitting and file it for your records. NOTE: You will not be able to download a copy of the submission after submitting it.
5. After downloading the submission, you may click the “Submit” button.
6. You will receive an acknowledgement email from the FDA, and it will contain the Event ID for the submission. This Event ID identifies the specific submission in the Portal.

Congratulations! You completed the submission of the Original IND Application.

Follow-up submissions (protocol amendments, annual reports, general correspondences, etc.) to your IND are also submitted via the Portal.

Please refer to the CDER NextGen Portal for additional information and FDA instructions on how to submit. These instructions may be accessed via your portal account once you sign in.

Contact OCR IND-IDE inbox for additional guidance

Close

Need recruiting tips or strategies? Thomas Hohing, OCR Recruitment Specialist, offers virtual recruitment consultations Mondays and Fridays 12:30 to 1:30 pm.by appointment.
Schedule Here

Close