Zemplar (P12-269) Study - P12
Contents
1. which starts with 1 in each center There is no way to modify the Patient ID during the Study Enrollment of a new patient 2 Patient Registration Patient ID 901 0030 T Help with patient registration In order to register a new patient to the database it is necessarry to submit the form above The patient ID is assigned automatically and can not be modified The patient registration commences when the Register patient button is pressed Note that if the system finds any will be halted Also note that after the registration it is not possible to modify the patient s ID 1 The Patient ID is given automatically by the eCRF program Please click Register patient button 16 Enrollment of a new patient 3 Message from webpage Patient Registration J This will register the patient it wil not be possible to modify the patient ID after this Continue Patient 1D 901 0032 k LI alin unth natant earurtentian After clicking the Register patient button a message box will appear Enrollment of a new patient 4 After enrollment of a new patient you can continue P12 269 eCRF one 7 amp Q0 Home Patient istration isit selectio ion Repo Help 1 with the enrollment of further new patients by choosing the Click here to register another patient Help with patient registration In order ta ee new patient to the hae fa bas rry to fill out the form2. Adverse Events present since last visit yes O no If yes please specify on AE page Serious Adverse Event since last visit yes O no In the event of a SAE in Zemplar cps treated patients whether related to Abbott product or not the physician has to notify the designated Abbott pharmacovigilance contact person by faxing the appropriate SAE forms within 24 hours of the physician becoming aware of the event As the result of a SAE the patient can be excluded from the study if the physician chooses to do SO 1 Adverse Event AE or serious Adverse Event SAE can be entered from Visit 2 a2 Message from webpage On ddverse Event has occured You will be forwarded to the corresponding Adverse Event form You will be able to cointinue filling out this Form later 1 Re DO rting an AE the following message will appear Mowe you sor ovee meme ot genet asa etek ee 2 The physician will be guided piz aso to AE page automatically All fields are required Multiple AE pages can be e created lo create a new AE EA page press the Create new a ee AE page button 3 The visit can not be completed if one of the AE forms is not closed 33 serious Adverse Event SAE 1 Ticking the SAE box on the AE page or visit page the following N eoestoneernsane B l message will appear R BE CAREFUL all SAE should be 1 and will be reported to the local Authority so you have t
3. Step 2 Select a patient Step 3 Fill out the form concerning the otudy and or the P4 eCRF y my a 2 Ashort description of the eCRF processing First step Since every patient in Second step Onces a patient is The final step When a P12 269 eCRF will have more then registered it will be possible to start to patient is selected the one visits itis necessary to identify fill out the visits This page is used to browser will be forwarded to them On this page the patient is select wich patient you want to start the visit s page The visits registered in the system with a unique working with also allows you to open the will have to be filled out in identifier visits directly this step Home Patient administration Visit s lection Downloads Administration Report Help Logout Help You have two choices under Help o P12 269 eCRF 1 Helpdesk you can find a telephone number here which can be used to contact our Helpdesk between 9 AM and 4 PM GMT 1 P12 269 eCRF t S 2 6 f If your call is not answered please leave a message containing your username protocol number E mail address and the full description of the problem 2 Manual The are two versions of the Manual a online version html b offline version pdf 10 Downloads The documents of the Study to be downloaded are available ee a 00 under the Downloads menu A S item If you want extra EE documents
4. Zemplar P12 269 Study User s Manual V2 1 http zemplar planimeter hu Study protocol 1 This is a non interventional observational open label multi country multicenter post marketing study in which Zemplar is prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose population and indication All patient data entered in the patient s case report form CRF will be forwarded without naming the patient for evaluation to Abbott In order to maintain patient confidentiality instead of date of birth the patient s year of birth will be documented in the CRF Inclusion Criteria 1 Patients gt 18 years 2 Patients with CKD stage 3 or 4 and also has SHPT 3 Patients with IPTH gt 70 pg ml and with CKD stage 3 or with 4 iPTH gt 110 pg ml and with CKD stage 4 5 Patients clinically indicated for the treatment with Zemplar cps 6 Patient must provide the authorization to use his her data for Statistical evaluation before entering to the PMOS Local Law requirements to be followed Exclusion Criteria 1 Patients with clinically important hypercalcemia Ca gt 2 6 mmol l 10 5 mg dL 2 Patients suffering from proven intoxication of vitamin D or patient with proven hypersensitivity of paricalcitol or any other part of the product User Activation 1 If you are a contracted physician of this study please provide your e mail address to the s
5. a SAE in zemplar cps treated patients whether related to Abbott product or not the physician has to notify the designated Abbott pharmacovigilance contact person by faxing the een VON lf the AE is classified during the entry of an AE serious that is the serious box Is ticked on the AE page then the SAE status will be changed to Yes on the Visit page too 36 AE SAE indicated by error e There is no way of direct modification deletion of an AE SAE entry If you reported an AE SAE erroneously and you would like to make changes or you would like to delete it then e You have to send a message via the menu item Message Board e Your request will be investigated by the local PMOS co ordinator and you will be noticed about the applied process and changes by and e mail 37 Concomitant medication 1 e You have to specify those medications whose Concomitant medication Center userl memory administration Please provide patient s concomitant medication I had started before the e a inclusion of the subject Date permanently d iscontinued Unknown and did not stop before cor C Inclusion a li started after inclusion Date permanently d iscontinued O unknown 38 Concomitant medication 2 1 Please give the name of the concomitant medication You have to ease Srnec ee e wane enter the name twice and only p ET completely identical entries are accepted You can not change this Please ent
6. abet or numbers but can not start with number 1 Changing the password after the first login is recommended but not obligatory admnistration Visit selection Downloads Administration epor ogout 2 To change the password choose the Administration tab 3 Choose the Change password option and follow the instructions Password management 2 1 Type your old still valid password 2 Type a new password do not forget the general rules English alphabet digits Please enter only alphanumeric characters from english and numbers Enter old password esses 1 and min 6 characters Enter new password jeeceees 2 IMPORTANT small and retype new password esescee 3 capital letters are 4 DIFFERENT 3 Re type the new password 4 Click the Change password button Home ur eE Bb 6e e The Home page as usual FF an _ is the center of the navigation amnem d You can reach here Welcome to the P12 269 eCRF How to use the P12 269 eCRF 1 N t The basic use of the P12 269 eCRF consists of threg steps Patient registration patient selection and filling out the eCRF Electronic Case Report Form CWS J a nN nN O u n ce e n S These steps have to be done in order however itis possible to register multiple patients in a row and only fill out their visits later More detialed information on each step can be found ont Step 1 Register a new patient
7. abow or The patient s verbal or signed informed c saat ie be flle ae ut The e patient ID i S file Pea ut a utomatically and can not be modified On the ae dhs Cee ad he slate nt registratio mmences when the Register patient button is pressed Note that if the sys e 2 Typing further data of the already enrolled patient s by choosing Click here to go to patient selection screen 18 Patient selection Patient Registration 901 0026 patient ID registered Click here to go to patient selection screen Luc ere to register another patient 1 Help with patient registration In order to register a new patient ta the database it is necesse The patient s verbal or signed informed consent has to be filled Onces the form has heen filled nut the natient renistratinn com me Patient admnistration Visit selection Wem patient Patient selection Further editing of Visit data can be reached after Patient and visit selection You can reach the Patient selection panel by 1 choosing the menu item Click here to go to patient selection screen after inclusion of a new patient See previous pages or 2 choosing the Patient selection option under the main menu s Patient administration menu item 19 ES P12 269 eCRF 901 0012 901 0014 Patient selection 2 1 You can give here the number of rows you would like to see on one screen 2 You can order the table into increa
8. er the same medicaton name again oo name later but the deletion of an Once the name was specified it can not be i changed later Only the start and finish date 7 entry IS possible can be changed 2 You have to give the start date of the conc Med If the exact date is 1 unknown please tick the Unknown Please provide patient s concomitant medication box and you will get a possibility to enter the starting year and month Name x 0 If the conc med was stopped the Date initiated J D unknown discontinuation date can be given with Date permanently discontinued fs O Unknown the application of the Previous rules 3 Discontinuation date can not be 2 earlier than the starting date Concomitant medication 3 1 Name dsf gt t EA a Aiea 43 Concomitant medication Date initiated a Unknown This field can not be modified If You would like to make changes Date permanently discontinued CO Unknown delete the item and add it again with the correct settings 2 Name x Delete 2nd Concomitant Date initiated CI Unknown medication Pressing the delete button this Date permanently discontinued CI Unknown concomitant medication will deleted Although the values remain visible they will be marked as deleted You can not withdraw 3 the deletion of a concomitant Name P X medication but you can add the item again in case of unwanted Date initiated Cc Unknown deletion a e You can not modi
9. fy the Message from webpage Are you sure you want to delete this Concomitant medication name of a CONCOM ita nt Press OK iF vou wish bo delete it Deletion can nok be undone ee es medication but you can delete with the red X and add it again in case of erroneous data entry 40 Concomitant medication 4 Even the deleted concomitant medication items are displayed with the watermark DELETED but no further edition of deleted concomitant medications is Supported 2 i Ma i N e Name ebe o A Date initiated Ls f Onn P SC Date permanently discontinued LT unknown 41 e Choose the Logout option 1 then click the logout button 2 to logout Current status This is your current status Llsername useri 2 Q 42
10. ge is not identical with normal ranges 22 Fill in rules and guides 2 The guide with one or several S rules to be fullfilled can contain Patient demographics wn a an acceptance range 1 see Peon SSe Mi in the weight of the the previous page or some DES other rule or restriction for the Before therapy with Zemplar cps is initiated the following data should be c data to be entered IN a certain A Date of visit a E m box 2 4 Weight 23 Icons of data entry process 1 This icon is for the restoration of the last saved version of the visit This button is useful if you would like to restore the last saved state of the visit ALL changes made after the last save will be LOST 2 THE ENTERED DATAARE NOT bd AUTOMATICALLY STORED ON THE Tae Sea ere SERVER YOU HAVE TO SAVE YOUR WORK p EA WITH THIS BUTTON All saved data of a certain visit are available for further editing TILL CLOSING THE VISIT AFTER CLOSING THE VISIT NO FURTHER MODIFICATION IS POSSIBLE on the given subject s visit 1 2 3 If a visit is closed by accident or you wish to re open it for any reason please make a request for this on the message board found under Administration gt Message board by writing a detialed description of the issue including the patient ID and the name of the visit to be opened An E mail will be sent to you about the decission of the PMOS If approved the visit will be opened for furthe
11. nt Pressing Cancel you can editicorrect any data of this visit With clicking the lt icon The current visit of the current patient will be saved and closed in other word frozen Further modification of already closed data is not supported by the system If a visit is closed by accident or you wish to re open it for any reason please make a request for this on the message board found under Administration gt Message board by writing a detialed description of the issue including the patient ID and the name of the visit to be opened An E mail will be sent to you about the decission of the PMOS If approved the visit will be opened for further editing z Q 28 Pop up messages 5 There are special patient Inclusion rules concerning some specific laboratory CA and iPTH data If the m p 7 Ra npn n sage rom webpage specified laboratory is The patient does not meet one of the specified requirements Y Only a patient who is not suffering From proved intoxication of vitamin E and has no hypersensitivity to paricalcitol or any other part of the product can O U ts q e of th z ra n g z g IVE n be included i by the protocol no inclusion Press OK if the patient is suffering From proved intoxication of vitamin Dor has hypersensitivity to paricalcitol or any other part of the product Then all of the patient s Visits will be closed automatically and the subject will be marked as a proc
12. o give all the SAE relevant information with utmost care 4 Reporting a SAE might result the teens exclusion from the study 4 Serious Adverse Event has occure d t In the event of a 54E whether related to a e ee ae a pleas Be the designated Abbott pharmacovigilance contact person by Faxing the a nee ina atin 24 hours of bec See t if T ue to participate in this 5 na cel if the patient w bee secluded From this stu dy Fs no Further visits will be avaiable for this patient 2 34 4a Outcome End date MMOD Pee Ongoing as ar MMOD Yay Filling in of an AE page Each question is obligatory on the AE page excluding the cases where the text implies a conditional answer e g information is obligatory if the duration of the AE is less then 24 hours Closing of all AE pages of a given visit is required to close that specific visit Save is naturally still available lf an AE is classified as serious then the exclusion of the subject from the study is an available option 35 Adverse Event AE e If there is a reported AE ona Visit it is Indicated with a green message Adverse Events present since last visit AE SAE This AE status can not be ara Events a since last visit yes O no modified a If YOu would like to If yes please specify on AE page fom a buco perform changes see the next Serious Adverse Event since last visit yes no slide In the event of
13. ol violator No Further data entry option visit will be available 5 7 For this subject IS possible Seamer area In such a case the visit will be closed by the system automatically and the patient will be excluded from the study 29 Other messages Patient demographics Year of Birth E 4 Gender O male female The value of this Field is expected to be between j 145 and 205 please make A cel gle sure the entered value is correct Height cm A Race Caucasian Black Asian Othe If a value outside of he acceptance range is entered a message will appear with green background The message will again show the acceptance range Clicking into this green box a confirmation of the value outside of the acceptance range will be accepted by the eCRF although the red border will indicate the special status of the value 30 Other messages 2 Before therapy with 7e Ekainan ienna Date of visit 6 lated the following data should be collected Errors which can not be left unsolved are indicated by messages with the red background These messages generally concern obligatory data with no data or for other fill in rules e g data of the 1 visit can be earlier than the Informed Consent date You have to click into the message to hide It but you also have to correct the data or give a value to an obligatory but still empty field 31 AE SAE AE SAE A
14. ponsor 2 Then you will receive e O yx CRF link from the service oesoem I sa e provider Planimeter Kft 3 Click on the link Zemplar eCRF does not allow open registration for users The participators were all assigned pre registered usersnames 4 h oose th e ki U se r In order to start working in Zemplar eCRF these usernames have to be activated first The username defined for each user co E mail address for example if you were registered with abcdef ghi jk as E mail address your username is abef Please fill out the form below 4 Activati O nN ta b Username 5 5 Follow the instructions on Home User activation Help the page a nN d Q ive YOu r Copyright 2010 Planimeter hu u se rn a m e 6 Click the Activate User button Login the system at first time 1 Choose the Home tab aE P12 269 eCRF pA J 2 Type your username into the Username box sl ea first time you re tryit ng to el eCRF then activat If you any trouble ne signing in ae e follow the ge TEE mae or call our helpdesk at 36 1 452 0546 on wor 3 Type the password you got ame E in an e mail AFTER activating your username Copyright 2010 Planimeter hu 4 Click the Login button Password management Password can be changed anytime after username activation Any password should contain at least 6 characters can not contain any other symbol than the letters of English alph
15. r editing 24 eg Pop up messages Windows Internet Explorer Th ere are many pop up messages to avoid the incorrect application of the eCRF e g to avoid leaving a Visit without saving the data by mistake T Ore vou sure vou want to navigate away From this page You are about to leave his page all non saved progress will be lost Continue Press OK to continue or Cancel to stay on the current page 25 Pop up messages 2 Message from webpage 2 This Will reset the visit all unsaved progress will be lost Continue After clicking the icon this message will be appeared With choosing the OK option the last saved visit data of the given patient will be restored ALL MODIFICATIONS SINCE THE LAST SAVE WILL BE LOST With choosing the CANCEL option no action will be taken 26 Pop up messages 3 Message from webpage oO The currenst state of the visit will be saved You can edit and modify these data later without restrictions With clicking the icon all the data of the actual visit will be saved to the server All these data will be available for further editing without any restricition 2 Message from webpage This will Finalize the visit Further modification will not be possible Continue Pe Pop up messages 4 Pressing OK this visit will be closed and the next visit will become avaiable For the patie
16. rs remarks 2 o 4 fea P12 269 eCRF gt amp 2 b amp b OORO S Home Patient administration Visit selection Downloads Administration Repor t Help Logout Change password Meccadne hoard Report an issue Browser in use 3 MS Windows XP Internet Explorer 6 Short description of the issue max 16 characters Full description of the issue 4 Attach a screenshot T Please give or type 1 The name and version of the operation system of your PC 2 The name and the version number of the web browser you used when the error problem occurred The version number of the web browser generally can be reached under the Help menu item of the WEB BROWSER 3 A short title of your remark or the reported error 4 A short description of the error or malfunction 5 There is a place to attach a screenshot BMP or JPEG format is preferred This step is optional 6 Your e mail address 7 Finally click the Submit form button 14 Home Enrollment of a New Patient Patient admnistration sit selection New patient Patient selection If you would like to enroll a new patient in the Study please choose the Patient administration menu item and then click the New patient menu item After the enrollment a new form is created with a patient ID like XXX XXXX The first three digits of the Patient ID is the center ID while the last four digits form a number
17. sing or decreasing order with clicking the small arrows in the columns 3 You can choose the required Visit by clicking the suitable visit icon in the row of the required patient 20 Definition of the Visit status 1 Start new visit this is an 1 empty visit No data has been Start a new visit entered yet ri gt 2 Continue a visit this is a Si saved visit There are some Continue a visit entered data and these data are stored on the server The 3 visit can be re opened and all the data are available for further Closed visit editing 4 3 Closed visit this visit is closed no further data entry or Approved visit data correction is allowed 4 Approved visit The already closed visit is approved by the country PMOS coordinator 21 Fill in rules and guides 1 There are some signes and rules to support the data entry process a There are obligatory data fields which can not be left empty 1 oe Sa b There are guides 2 to support i E missing value is the data entry process These guides generally give the E Move your cursor over the icon to get acceptance ranges of the given Information about the acceptable values 2 variables Acceptance range means a clinically and or physiologically meaningful range Within this range all value is automatically accepted Otherwise a further confirmation is required to enter a value outside of the acceptance range The acceptance ran
18. to be placed here hae contact your country PMOS ET y samntenccr coordinator e Protocol of the Study e Concomitant medication page e Adverse Event Page Downloads 2 1 By clicking a document s name amessage box will 2 6 f appear offering the Do you want to open or save this file a e tocol zemplar cpa version on zo 0c c of th e d O C u m e nt O r S gyi n g Type Microsoft Word dokumentum 305KB P12 269 eCRF B a P12 269 Protocol The protocol of this study From teszt2 planimeter hu A A T the document for further Downloadable version of the Concomitant medication page a Adverse Event CRF 7 V Always ask before opening this type of file Downloadable version of the Adverse Event eCRF Z di While files from the Internet can be useful some files can potentially U S e m C2 bet a ra aaa lr you 3 not trust the source do not open or Home Patient admni wh ort Help Logout Copyright 2010 Planimeter hu 12 Reporting of errors remarks There is an option to indicate malfunction of the eCRF system to the developers directly via the menu item Message board To send a message or remark to the Planimeter developers please choose the Administration menu item from the main menu and then choose the Message board option The reported phenomena will be investigated and commented through this system as well Reporting of erro
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