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Re: harlem111 post# 28475

Wednesday, 01/12/2011 12:24:47 PM

Wednesday, January 12, 2011 12:24:47 PM

Post# of 92948
harlem,

While it is possible to enroll a patient prior to submitting protocol to clinicaltrials.gov it seems many start recruitment after submission for possibly the reason below. No info at the site ..yet.

From January 3 ACT PR,

"Specific inclusion and exclusion requirements and Investigator contact information will be posted shortly at clinicaltrials.gov. Patients and their caregivers should refer to this source rather than contacting ACT or its representatives."
____________________________________________________________________

the registration of certain “applicable clinical trials” (see Definitions) in ClinicalTrials.gov no later than 21 days after the first subject is enrolled
http://grants.nih.gov/Clinicaltrials_fdaaa/index.htm?print=yes&;

ClinicalTrials.gov facilitates registration of trials in accordance with the International Committee of Medical Journal Editors (ICMJE) initiative requiring prior entry of clinical trials in a public registry as a condition for publication.

The International Committee of Medical Journal Editors (ICJME) has established a requirement that all clinical trials be entered in a public registry before the onset of patient enrollment, as a condition of consideration for publication.
http://prsinfo.clinicaltrials.gov/

Why can I not find my trial in ClinicalTrials.gov?
After a protocol record has been entered (or modified) and marked as ‘Complete’, it must be approved and released by a PRS administrator. From the time the record is released, it normally takes between 2 and 5 working days for internal quality assurance review and processing for publication on the ClinicalTrials.gov website. Records that contain Results may take up to 30 days.
http://healthcare.partners.org/phsirb/ct.gov_faqdetails.htm




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