ClinicalTrials.gov Instructions for User Account Set-up & Registering Your Trials

Transcription

1 ClinicalTrials.gv Instructins fr User Accunt Set-up & Registering Yur Trials INSTRUCTIONS FOR REGISTERING YOUR CLINTRIALS.GOV RECORD 1 Backgrund University f Hustn researchers are respnsible fr registering their trials and shuld use the web based data entry system called the Prtcl Registratin System (PRS). Access t the PRS system is at and requires a user name and passwrd. 2 T set up a user accunt and passwrd: a. Send an message requesting an accunt t: avargas5@central.uh.edu r tyhlden@central.uh.edu. b. Include CT.gv in the subject line. c. Include in the message yur full name and telephne number d. Yu will receive by return a lgin name and a temprary passwrd. e. Lg int the PRS system using yur lgin name and temprary passwrd. f. Navigate t the Accunts tab and select Change Passwrd t replace yur temprary passwrd with smething yu can remember. 3 T register yur trial: a. G t the Clinicaltrials.gv Registratin (URL is b. Cmplete the lgin fields. In the Organizatin field, enter in the rganizatin name, UHustn

2 ClinicalTrials.gv Instructins fr User Accunt Set-up & Registering Yur Trials c. Refer t the User s Guide fr additinal infrmatin. As the PI, yu are a user, and yu are respnsible fr entering the infrmatin abut yur trial, ensuring that the infrmatin is crrect, and updating the infrmatin in a timely manner. d. On the Main Menu page, under Prtcl Recrd, hit "Create" and cmplete the study descriptin template. Prtcl Recrds Create Mdify View QA Review Cmments Prblems: Undelete e. Nte that the ClinicalTrials.gv-required fields are marked with a red asterisk (*) and the FDA-required fields are marked with a green FDAAA. Taken tgether, these data elements represent the requirements fr an adequate registratin. If yu d nt cmplete these fields, yur trial may nt be cnsidered "fully registered." Nte als that each field f the template is labeled and linked t a definitin; f. Several fields are ptentially cnfusing and shuld be cmpleted as fllws:

3 ClinicalTrials.gv Instructins fr User Accunt Set-up & Registering Yur Trials Organizatin s Unique Prtcl ID: Use the IRB prtcl number (ID#) EXAMPLE: STUDY00000XXX. This number can be fund n any fficial IRB crrespndence r by cntacting cphs@uh.edu. Study Identificatin Unique Prtcl ID: STUDY00000XXX Brief Title: Testing Testing 123 Official Title: Testing Testing 123 Lngitudinal Sudy Secndary IDs: Recrd Verificatin Date: Enter the mnth and year n which yu cmplete and submit the template. Nte: This field generates autmatic reminders, d nt leave it blank. Study Status Recrd Verificatin: August 2015 Overall Status: Nt yet recruiting Study Start: August 2015 Primary Cmpletin: February 2017 [Anticipated] Study Cmpletin: August 2017 [Anticipated] Respnsible Party: This shuld always be the Principal Investigatr, even thugh the system defaults t spnsr. Spnsr: The database will default t University f Hustn. Althugh University f Hustn is nt actually the financial spnsr, chse University f Hustn. Cllabratrs: Spnsrship can be clarified by entering the actual spnsr s name. Fr unspnsred research, either leave the field blank r enter "Nne. Spnsr/Cllabratrs Spnsr: University f Hustn Respnsible Party: Principal Investigatr

4 ClinicalTrials.gv Instructins fr User Accunt Set-up & Registering Yur Trials Investigatr: Jhn Smith [jsmith] Official Title: Assistant Prfessr Affiliatin: University f Hustn Cllabratrs: Sciety f Physicians US University Industry Pharmaceuticals, Inc. Oversight: Fr the Review Bard, enter yur IRB apprval status and use the IRB ID#. Fr Bard Name use University f Hustn Institutinal Review Bard Fr Bard Affiliatin use University f Hustn. g. If the PI did nt persnally cmplete the template, send the draft template t him/her fr review and apprval. Nte: This is an imprtant step. The PI needs t have their wn PRS user accunt and be listed as the Respnsible Party fr the study. If they are nt in the system, avargas5@central.uh.edu r tyhlden@central.uh.edu as nted abve under #2 t request an accunt. h. Submit the cmpleted, PI-apprved template by clicking n Cmpleted at the tp f the nline template. i. The Principal Investigatr must next release the template t ClinicalTrials.gv by clicking n Release at the tp f the nline template. j. The study recrd will be released t the PRS team.

5 ClinicalTrials.gv Instructins fr User Accunt Set-up & Registering Yur Trials k. The PRS team will d their wn quality assurance check. If they have n cmments r changes, the study recrd will be published r updated n the ClinicalTrials.gv website in 2-5 business days. INSTRUCTIONS FOR COMPLETION OF YOUR CLINTRIALS.GOV RECORD Sectin Field Field Nte Study Status Study Start Mnth/Day/Year the study starts enrllment Primary Cmpletin Date Final data cllectin date fr primary utcme measure (Mnth/Day/Year; NOT when the study is clsed with the IRB) Spnsr/ Cllabratrs Oversight Study Cmpletin Date Respnsible Party Cllabratrs U.S. FDA-regulated drug U.S. FDA-regulated device Bard Infrmatin Final data cllectin date fr the study (Mnth/Day/Year; NOT when the study is clsed with the IRB) This shuld always be the Principal Investigatr, even thugh the system defaults t spnsr. Spnsr: The database will default t University f Hustn. Althugh University f Hustn is nt actually the financial spnsr, chse University f Hustn. Organizatin(s) prviding supprt: funding, design, implementatin, data analysis r reprting. Include all cllabratrs n the research prject. If the study is funded by the NIH, include the name f the agency. Yes/N Des the study invlve an FDA-regulated drug r bilgic? Nte: this is nt asking if the drug is investigatinal. Yes/N Des the study invlve an FDA-regulated device? Nte: this is nt asking if the drug is investigatinal. Name: University f Hustn Institutinal Review Bard Affiliatin: University f Hustn Phne: (713) cphs@central.uh.edu Address: Institutinal Review Bard, University f Hustn 4800 Calhun, Hustn, TX 77004

6 ClinicalTrials.gv Instructins fr User Accunt Set-up & Registering Yur Trials U.S. FDA IND/IDE Study Sectin 801 Clinical Trial Yes/N Yes if the study is being cnducted under an IND r IDE. Answer NO if the study is being cnducted under an IND exemptin r did nt require FDA review. Sectin 801 Clinical Trial: Yes/N Is the study an applicable clinical trial? Study Descriptin Brief Summary Shrt descriptin f the prtcl intended fr the lay public, i.e. The purpse f this study is t determine Cnditins Study Design Arms and Interventins Outcme Measures Cnditins r Fcus f Study Depends n the Study Type Interventins Outcmes Time Frame The name(s) f the disease(s) r cnditin(s) studied in the clinical study, r the fcus f the clinical study. Cmplete fields based n the type f study (i.e. interventinal, bservatinal, expanded access) Include all interventins that the participants will receive. This includes any investigatinal agents AND when applicable, standard f care treatment. A cncise name fr the specific measure that will be used t determine the effect f the interventin(s) r, fr bservatinal studies, related t cre bjectives f the study and receiving the mst emphasis in assessment. Describes what will be measured and nt why it is measured. All primary and secndary utcme measures listed in the prtcl must be included. The utcme measures listed in this sectin will be used fr the results sectin. Time pint when utcme measure is assessed. Each utcme measure can nly have ne time pint. If multiple utcmes are based n the same underlying measure assessed at different time pints (i.e. 8 weeks, 12 weeks and Final Visit), then each unique cmbinatin f measurement and time frame is entered as a separate utcme measure (i.e. Change frm Baseline t Week 8 in MMSE/ Baseline t Week 12).

7 ClinicalTrials.gv Instructins fr User Accunt Set-up & Registering Yur Trials A nte n Outcmes Outcmes using a scale Example 1 Example 2 The fllwing infrmatin in the Outcme Measure Descriptin field: All scale ranges (i.e., minimum and maximum scres) required t interpret any values in the data table. Fr example, if the *ttal* scre is reprted, the *ttal* range shuld be prvided. If subscale scres are reprted, the range fr each subscale shuld be prvided. Fr each scale range prvided, specify which values are cnsidered t be a better r wrse utcme (i.e., D higher values represent a better r wrse utcme?). If subscales are cmbined t cmpute a ttal scre, cnsider indicating hw subscales are cmbined (summed, averaged, etc.). Title: Systlic Bld Pressure Outcme measure descriptin: Change in Systlic Bld Pressure Title: Parkinsn s Disease Questinnaire 39 (PDQ-39) Outcme measure descriptin: The PDQ-39 is a measure f quality f life in Parkinsn's disease patients. It has 39 questins each with a respnse frm 0-4 fr a ttal f 156 pints. The ttal scre is calculated as a percentage s the scres f the 39 items are added and divided by 156 and multiplied by 100. The higher the scre the wrse quality f life. All cllected data fr pre-specified Primary and Secndary Outcme Measures shuld be reprted. Data cllected fr explratry utcmes can be included but is nt required. Eligibility Eligibility Include prtcl specific inclusin/exclusin criteria. Eligibility criteria shuld be entered in a bulleted list. Cntacts/Lcatins Central Cntact Designate a member f the study team (PI, Subinvestigatr, Study crdinatr) wh ptential participants can cntact fr mre infrmatin. This persn shuld be available via phne r t field questins abut the study. When a Central Cntact is listed, a cntact fr each study lcatin des nt need t be listed.

8 ClinicalTrials.gv Instructins fr User Accunt Set-up & Registering Yur Trials References Citatins / Links / Include any and all citatins/links relevant t the study in Available Study Data this sectin. If yu include this infrmatin in any ther and Dcuments sectin (i.e. detailed descriptin), Clinicaltrials.gv will require yu t mve it befre apprving the registratin. INSTRUCTIONS FOR UPDATING YOUR CLINTRIALS.GOV RECORD 1 General Infrmatin Studies listed as recruiting n the ClinicalTrials.gv website need t be updated at least every six mnths, r mre ften if there are ANY changes t the infrmatin presented in the ClinicalTrials.gv study template, including changes in recruitment status, cntact persns, etc. Updates can be made at any time, as needed. Updates are made in the Prtcl Registratin System (PRS) by the persn wh des the data entry n the study recrd. This persn is called the wner f the study recrd. 2 T update the study recrd: 1. The wner needs t update the study recrd by ging t and lgging in using the rganizatin name (UHustn), their individual Username and Passwrd. 2. Lcate the study and click n Open t view the recrd in mre detail. Navigate t the sectin(s) yu wish t update, pen them, and edit the infrmatin. 3. Ensure that all ther infrmatin assciated with the registratin is current and accurate. 4. Make sure t update the Verificatin Date in the Prtcl Sectin, Study Status t reflect the current mnth and year that yu cmpleted yur edit and re-review. The Verificatin Date is the field which generates autmatic reminders within the PRS system, and cannt be left blank. 5. When dne updating the recrd, please remember t hit Cmpleted at the tp f the template. 6. The PI will then need t release the study recrd t the ClinicalTrials.gv (PRS) team. 7. Publicatin f the update takes 2-5 business days because the PRS team des their wn quality assurance check.