Phase 1 Trial Registration on PRS

$1500-4000 USD

Closed

Posted 7 days ago

$1500-4000 USD

Paid on delivery

I need assistance in creating a [login to view URL] PRS record and obtaining an NCT number for my Phase 1 interventional clinical trial focused on prevention. Requirements: - Comprehensive knowledge of [login to view URL] registration process - Experience with PRS (Protocol Registration System) - Familiarity with interventional study protocols, especially in Phase 1 trials - Attention to detail to ensure accuracy and compliance with regulatory standards Ideal Skills: - Background in clinical research - Strong organizational skills - Ability to navigate governmental and regulatory platforms

Project ID: 40712405

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24 proposals

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Active 3 days ago

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24 freelancers are bidding on average $2,783 USD for this job

@AcademicProof

Hi, I am very interested in this project. I am a PhD Medical Writer, Clinical Researcher and Medical Journal Editor with more than 25 years' experience. I have published over 70 medical research papers and am a native English speaker. Please review my portfolio to see examples of my work and we can discuss further via chat. Thanks!

$3,000 USD in 7 days

4.8

(19 reviews)

6.5

@mengw3

I have built and run hospital information systems in production for more than 15 years: HIS, LIS, PACS, and MMP, a medical administration platform delivered end to end for a hospital. That work is protocol data, controlled vocabularies and records that have to hold up under audit, which is the same discipline a PRS record needs. For a Phase 1 interventional prevention study the record stands or falls on a handful of fields: study design and arms, interventions, eligibility criteria, primary and secondary outcome measures with their time frames, and the responsible party, sponsor and oversight declarations. Drafting those from the protocol and working the PRS reviewer comments through to a released NCT number is right in my range. Two things I would want in hand before starting: the final approved protocol with its version number and date, and confirmation of who is registered as responsible party and record owner on your PRS account, since that determines who can submit and who answers the review comments. Please contact me to discuss details.

$2,500 USD in 7 days

5.0

(1 review)

3.1

@itisabdirahman

Imagine registration completed accurately enough that you are not revisiting it months later to correct fields. That is the standard I would hold. I would review your study documentation, enter the required information in the PRS, cross-check the record against your protocol for consistency, and submit once everything aligns. The NCT number would be provided after assignment. Any follow-up clarifications from the registry would be handled as part of the work. I am ready, hope you are ready too.

$2,750 USD in 7 days

0.0

(0 reviews)

0.0

@BenEyck

What's prompting the registration? Worth knowing, because the reason (ICMJE, NIH, an IRB condition) shapes how the record should be written. And what exactly is the intervention? The Phase field in PRS applies to drugs and biologics. If yours is behavioural, dietary or device-based, the record usually won't reflect Phase 1, regardless of what the protocol calls it. I'm a physician with a PhD in oncology from Erasmus University Rotterdam, 40+ publications, and I've led phase I through III trials across Europe and East Asia. I run a biotech company myself now, so I also see this from the sponsor's side. I've spent enough time defending outcome measures to know PRS review comes back to them almost every time. One practical point: the PRS account belongs to your sponsor organisation and the responsible party has to be you or your PI, so I'd work inside your account as a delegated user. I'd take the protocol into the full PRS data set, build the outcome measures to specification and check them against what you'll need at completion and publication, run a review round with you and your PI, submit, and work the QC comments through to publication. I stay with it until it's live. Outside scope: protocol writing, IRB submission, the SAP, results posting. $3,000 fixed, a third at start, a third at submission, a third when the NCT number publishes.

$3,000 USD in 7 days