Study Data Reviewer’s Guide
Create your Clinical Study Data Reviewer’s Guide (SDRG) with one easy click
Automate content aggregation and formatting with our SDRG automation tool
Regulatory agencies really need a steer when navigating your clinical data submission package. That’s why it’s beneficial to provide a clear and detailed account of your data, in the form of a Study Data Reviewer’s Guide (SDRG). Although not mandatory, the SDRG provides much needed clarity – which only serves to expedite the clinical study review process.
Collating and formatting this information can be a painstaking task. But with Pinnacle 21 Enterprise (P21E), it’s a walk in the park! Use our study data reviewer’s guide template, and the platform aggregates your existing data, and sorts out the formatting for you. So all that’s left is to push a button and auto-generate your Reviewer’s Guide!
Why create your Study Data Reviewer’s Guide in P21E?
Pre-populate your SDRG
Manually collating and formatting your content is time-consuming and inefficient. The P21E platform pre-populates your study data reviewer’s guide template with trial design and summary, subject data, study metadata, and validation results. The formatting is all done for you! And this applies across clinical, non-clinical, and analysis data, including SDTM, SEND, and ADaM.
Import existing issue explanations
Alot of time is spent tracking down explanations in the run up to submission. But rather than duplicating work, with P21E you can reuse existing study content. So if you’re using our Issue Management module, your explanations will already be approved. Simply import them straight into your Study Data Reviewer’s Guide!
Auto-generate your SDRG
With content and formatting taken care of, all that remains is to generate your finished document. The P21E platform automatically creates your Study Data Reviewer’s Guide – with a simple click of a button! Now you can effectively communicate valuable information to FDA reviewers, whilst saving time and resources in the process!
Push a button… out pops your Study Data Reviewer’s Guide!
How you’re better off with our Study Data Reviewer’s Guide tool for your FDA submissions
Maximize chances of FDA approval
Providing a SDRG helps reviewers understand any special considerations or directions related to your FDA submission data. Without it, your data could be open to misinterpretation, or may lack valuable context. P21E’s SDRG automation platform equips you with the tools to thoroughly and efficiently advocate for your data, and persuade reviewers – boosting your chances of submission approval.
Avoid submission delays
Rather than manually digging around for issue explanations at the last minute, pre-approved explanations can be instantly imported into your reviewers guide. Now you can avoid the risk and stress of submission delays when finalizing your reviewers guide.
Gain efficiencies
With a pre-populated SDRG template, imported issue explanations, and formatting taken care of, you’ll save lots of time consuming manual work. And with one-click to generate your reviewers guide document, you’re making even more time and resource efficiencies.
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Study Data Reviewer’s Guide FAQs
The purpose of the SDRG is to thoroughly explain the clinical trial submission data, since it often diverges from ‘the norm’ and requires further clarification. It provides a mechanism to preempt potential queries and present supporting information or context upfront – to avoid ambiguity and make it easier for FDA reviewers to understand.
The document contains information related to the clinical study, including: the study design; data standards; data collection; and description of the datasets. It also contains special considerations or guidance that could help the agency reviewer understand the correlation between the study report and supporting data.
Yes! There are various versions of the SDRG, and the Pinnacle 21 Enterprise platform includes its own easy to follow template. The SDRG template follows a typical structure, but it’s also flexible enough to be customized accordingly. Some sections can be ignored if not applicable, and likewise additional content may be added as needed. Using a Study Data Reviewer’s Guide template means you’ll be providing FDA reviewers with all the information they’re expecting. So it’s an extremely beneficial tool to have!