Master the IRB submission pipeline at portfolio scale — initial submissions, continuing reviews, amendments, and safety reports flowing through multiple IRBs simultaneously. This course covers multi-IRB navigation, regulatory authority interactions including FDA Form 1572 management and clinical holds, and the stakeholder communication systems that keep submissions moving across every active study at your site.
Studied within the Regulatory Coordinator track. One payment of $179 USD covers all seven courses and the certificate.
Eight modules and thirty-one lessons, each module closing with a knowledge check, and a final exam to complete the course.
Each is open now, exactly as enrolled learners read them. Every lesson in the course is written, cited and narrated the same way.
Defines the operational shift from per-study submission execution to portfolio-level pipeline management, identifying five pipeline-only capabilities and the failure modes that emerge without them.
Read the lesson freeQuantifies the operational and regulatory consequences of a continuing review lapse and establishes the early-warning infrastructure that prevents it across a multi-study portfolio.
Read the lesson freeAnalyzes the commitments embedded in FDA Form 1572 per 21 CFR 312.53, designs portfolio-level 1572 maintenance tracking, and evaluates the regulatory risk of outdated investigator information across IND studies.
Read the lesson freeClear enough to read between site visits.
Each point links back to its section of the guideline.
Listen when you can’t sit down to read.
Pick up exactly where you stopped.
Regulatory Submissions & Stakeholder Management is the second of seven courses in the Regulatory Coordinator track. It is not sold on its own: one enrollment opens every course, every final exam and the certificate.
Portfolio-level regulatory operations training for clinical research sites
Pass every final exam and your credential is issued, with the printable certificate included.
A public verification record you can share as a link, and the printable certificate. Both included.
New to clinical research? Begin with Good Clinical Practice, free to study. Its PDF certificate is optional, at $29 USD.
See the free GCP trackHow it is enrolled in, what the exam asks, and what you can read first.
Not separately. Regulatory Submissions & Stakeholder Management is the second course in the Regulatory Coordinator track, and the track is enrolled in as one: all seven courses, every final exam and the certificate, for one payment of $179 USD.
Fifty-five questions in 75 minutes, with 80% needed to pass, and up to three attempts. Each module also closes with a knowledge check.
Yes. Three lessons are open now: “From single-study submission to submission pipeline management: the RC's operational shift”, “Continuing review timelines and the cost of a regulatory lapse” and “FDA Form 1572: what it commits your investigator to, and when it needs updating”.
Yes. The course works from ICH E6(R3).
No. Access is yours for good. The Regulatory Coordinator credential the track awards is valid for two years.
One enrollment opens all seven courses, every final exam and the certificate. Course access does not expire.
One payment of $179 USD. The certificate is included.
Not separately. Regulatory Submissions & Stakeholder Management is the second course in the Regulatory Coordinator track, and the track is enrolled in as one: all seven courses, every final exam and the certificate, for one payment of $179 USD.
Yes. Three lessons are open now: “From single-study submission to submission pipeline management: the RC's operational shift”, “Continuing review timelines and the cost of a regulatory lapse” and “FDA Form 1572: what it commits your investigator to, and when it needs updating”.
Each is open now, exactly as enrolled learners read them. Every lesson in the course is written, cited and narrated the same way.
Defines the operational shift from per-study submission execution to portfolio-level pipeline management, identifying five pipeline-only capabilities and the failure modes that emerge without them.
Read the lesson freeQuantifies the operational and regulatory consequences of a continuing review lapse and establishes the early-warning infrastructure that prevents it across a multi-study portfolio.
Read the lesson freeAnalyzes the commitments embedded in FDA Form 1572 per 21 CFR 312.53, designs portfolio-level 1572 maintenance tracking, and evaluates the regulatory risk of outdated investigator information across IND studies.
Read the lesson freeClear enough to read between site visits.
Each point links back to its section of the guideline.
Listen when you can’t sit down to read.
Pick up exactly where you stopped.
New to clinical research? Begin with Good Clinical Practice, free to study. Its PDF certificate is optional, at $29 USD.
See the free GCP trackStudied within the Regulatory Coordinator track. One payment of $179 USD covers all seven courses and the certificate.
One enrollment opens all seven courses, every final exam and the certificate. Course access does not expire.
One payment of $179 USD. The certificate is included.
A public verification record you can share as a link, and the printable certificate. Both included.
