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PTJ Policy

PTJ Policy. Trials that began participant enrollment AFTER January 1, 2009, must be registered in an accepted trial registry BEFORE enrollment begins. Trials that began enrollment BEFORE January 1, 2009, must be registered prior to manuscript submission. Authors are required to:

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PTJ Policy

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  1. PTJ Policy • Trials that began participant enrollment AFTER January 1, 2009, must be registered in an accepted trial registry BEFORE enrollment begins. • Trials that began enrollment BEFORE January 1, 2009, must be registered prior to manuscript submission. • Authors are required to: • (1) Specify where the trial is registered and provide the trial's unique registration number in their cover letter. • (2) Include in their cover letter a statement regarding when enrollment began. Physical Therapy

  2. Registries • ClinicalTrials.gov (http://www.clinicaltrials.gov) [FREE] • International Standard Randomized Controlled Trial Number (http://www.controlled-trials.com/isrctn/) • www.anzctr.org.au • www.umin.ac.jp/ctr/index/htm • www.trialregister.nl • https://eudract.ema.europa.eu/ (new registrations after June 20, 2011) • The World Health Organization (WHO) also has a registry network. Physical Therapy

  3. Physical Therapy

  4. PTJ Editorial Office Intake • Developed a matrix • Determined how the author labels the trial • Trial registration number • IRB approval • Consolidated Standards of Reporting Trials (CONSORT) Checklist • Page numbers in the manuscript Physical Therapy

  5. PTJ Editorial Office Matrix Physical Therapy

  6. Trial Team • Reviews the actual registration and date when the patient was enrolled….if registered AFTER, then immediate reject • If report of the trial is different from what is in the trial registry, seek author clarification Physical Therapy

  7. Content Review Team • Editorial Board Member & Reviewers • Content expertise Physical Therapy

  8. Issues • Unaware of clinical trial registry • Unclear about design type • Mechanistic studies • Failure to annotate the CONSORT checklist • Lack of IRB approval • Study underpowered • Substantial changes in reported variables compared with the trial registry Physical Therapy

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