ClinicalTrials.gov / PRS Made Simple

 

Learn protocol registration and result disclosure for fast and accurate entry into ClinicalTrials.gov/PRS.

We design our courses act as both basic learning and also quick reference if you forget. We keep each lecture short and focused to fit into your busy schedule and provide that just-in-time learning that works best for adult learners.

What PIs Need to Know

About Compliance Monitoring

By FDA and NIH

Courses Offered for Registry Compliance

Protocol Registration: Learn to enter and update your study

UPDATED to include the Final Rule and the NIH Policy.

Our on-demand video training will help  you to create and update your protocol registration quickly and accurately. The training also acts as an invaluable reference tool.

  • Understand the critical elements of the new regulations
  • Know what data to enter, by whom and when
  • Step-by-step instructions for data entry
  • Responding to CTG QC
  • Updating your record
  • Avoiding enforcement actions, fines, loss of grant funding and other penalties.

PRICE: Please click here for introductory discounts

Duration: 1h 46m

Format: 37 short, engaging video lectures. View only those that you need.

Content: Roles and workflows in ClinicalTrials.gov;  Understand the new regulations; Quality data entry; “applicable” clinical trials; Study ID and type; entering status; description; arms & interventions; outcome measures and much more.

Result Summary: Learn timely and accurate disclosure processes

Our on-demand video training will show you how to create and update your result summary record quickly and accurately.

  • The implications of the changed regulations
  • What data to enter, and by when
  • Step-by-step instructions for data entry
  • Partial and full full records
  • Responding to CTG QC
  • Updating your record, and when this obligation is complete
  • Avoiding enforcement actions, fines, loss of grant funding and other penalties.

PRICE: Please click here for introductory discounts

Duration: 2h 25m

Format: 33 short, engaging video lectures. View only those that you need.

Content: Roles and workflows in ClinicalTrials.gov;overview of result summary entry; quality data entry; updating teh protocol first; participant flow; baseline characteristics; outcome measures;  adverse events and much more.

Discounted access to BOTH invaluable training Courses

Access both the Protocol and Results training courses at a discount!

PRICE: Please click here for introductory discounts

Duration: 4h 08m

Format: 46 short, engaging video lectures. View only those that you need.

Content: Access the combined content of both the Protocol Registration AND the Result Summary Courses

Request your FREE Risk Assessment

Understand your exposure
to possible fines and loss of grant funding.

Our 4 Step Process to Organizational Compliance

Assess Your Risk

Understand your current risk profile and how to optimize compliance

Raise Awareness

Educate your organization on your compliance risk and create an action plan

Train Your Teams

Engage in short, focused professional training from ComplianceTime.com



Maintain Oversight

Monitor your organization’s compliance, and keep abreast of industry trends

A Simple, Fast Solution to Mitigate Your Registry Compliance Risks

Navigating both the ClinicalTrials.gov interface, the updated FDAAA regulation and the new NIH Policy can be confusing.

We offer a complete solution, including risk assessment, raising organizational awareness, training your clinical research teams and providing ongoing compliance oversight.

1: Risk Assessment

We begin by providing a Free Assessment of your organization’s exposure resulting from compliance failure. A quick telecon lets us gather your internal information. We blend this with external data and finally craft this into an actionable report that you can use to alert Management to your organization’s risk of losing NIH grant funds.

2: Awareness

Next we help you raise awareness in your organization – both of the new regulations and the implications for grant funding. This can be a daunting job, but we have proven solutions that will work within your organization’s dynamics to raise awareness, build consensus and drive action.

3: Training for FDAAA

A critical step. We offer cost effective adult learning programs built from a series of granular, engaging videos designed to help your teams quickly and confidently enter and maintain your clinical registry records for both protocols and summary results. Each learning module provides step-by-step instruction to guide users through the intricacies of both the regulations and the PRS interface. All Courses include access to our FLEXLinks document for fast and easy reference.

Our Courses are designed to quickly build competence and confidence. Whether you are new to trial registration or only enter data infrequently, we can help.

4: Compliance Oversight

Finally let us help you manage ongoing compliance through our monthly or quarterly outreach programs. Working directly with you or your PIs and clinical teams we can help alert you to trials at risk of compliance failure, enabling you to reduce the risk of loss of NIH grant funding.