EUDRACT USER MANUAL - Get EudraCT Number
Contents
1. 2 Press the Get EudraCT Number button In this instance the system will issue a EudraCT Number but the warning that you have used duplicate Sponsor s Protocol Code Number will be included in the e mail sent to the e mail address on the EudraCT Number request form 1995 2004 EMEA Page 14 of 19 Eudra EUDRACT USER MANUAL GET EUDRACT NUMBER Hips a Application for EudraCT Number Message Plain Text Unicode UTF 8 File Edit View Insert Format Tools Actions Help o Reply Reply to All W I Forward amp d BS x e A M From EudraCT eudra org Sent Fri 12 03 2004 10 43 Gregory Martin GE Subject Application For EudraCT Number The EudraCT number 2004 000271 34 has been issued for your Sponsor s Protocol Code Number Prot 123 2004 WARNING This Sponsor s Protocol Code Number has already been used for a clinical trial It is likely that a EudraCT number for this Protocol Code Number has already been issued to another individual within your organisation or another collaborator on this trial Please check whether you have duplicated this EudraCT number request for your clinical trial THIS IS AN AUTOMATED EMAIL PLEASE DO NOT REPLY AS EMAILS RECEIVED AT THIS ADDRESS WILL BE AUTOMATICALLY DELETED Fig 15 Duplicate Sponsor s Protocol Code 6 3 5 Using an invalid security code If an invalid or expired security code is entered then the following messages will appear when the Get EudraCT Number l2. BE ENCOUNTER BD EE 13 6 3 1 Not entering mandatory data scat statist taniuatstiidasousinda nD buaivait usinudictlbuatdiidirousindea PoanieaiebusimndaOiaa subusedaSiacncpeeis 13 6 3 2 Entering an invalid e mail address format cccccccccccccsscsseeee cece cece cece cece cece cece cece ee ee EE ELLE EE EE ELLE EE EE EEE E EEE LEER EEE 13 6 3 3 EE 14 6 3 4 Duplicate Sponsor s Protocol Code Number egene eege EES e 14 6 3 5 Using aninvalld SCCUVID COGS ssori airen ar TE EN a E 15 6 3 6 E E E EE 15 6 3 7 Using a security code more than ONCE wirceccccccccccccece eee aaa aaa aaa aaa aaa aa aaa 16 6 3 8 EE Eed 16 6 3 9 EE CITOS ee 16 De GOSS AT OE TING oases cows aos casas a ate a tcc dec sass en Aaa NE AEE Ea 18 8 SUMMARY OF SYSTEM ERROR MESSAGES cccsssssssssssssssssssscsssssssssssssssssssssssscsssssssssssssssssssssssssssssssens 18 1995 2004 EMEA Page 2 of 19 Eur T EUDRACT USER MANUAL GET EUDRACT NUMBER Hips a 1 ABOUT THIS DOCUMENT This document describes the first part of the EudraCT system from a user perspective It describes how the system can be used to obtain a EudraCT number but does not attempt to describe the business processes required by the Sponsor or Requestor to manage the request for or use of the EudraCT number 2 SYSTEM OVERVIEW 2 1 General The system is divided into two parts The first part is aimed at providing a security code reference as a means of validating the EudraCT Number request The second part
3. EMEA Page 5 of 19 Doc id Eudra C T EUDRACT USER MANUAL GET EUDRACT NUMBER A 5 REQUESTING A EUDRACT SECURITY CODE 5 1 Introduction A EudraCT Security code is needed in order to make a successful request for a EudraCT Number The security code will be valid for only 24 hours from the time is received and can be used for only request for a EudraCT Number It is therefore not good practice to obtain security codes too far in advance of the EudraCT number request that they are required for 5 2 The Process for Obtaining a Security Code To obtain a security code use the following sequence 1 From the EudraCT Welcome Screen take the link If you require a security code please press this link The following screen will appear Get Security Code Fields marked with must be completed When you have completed the form press the Get Security Code button and an e mail with a Security Code will be sent to the e mail address entered If you wish to cancel this application for a security code then press the Cancel button which will return you to the main menu Requestor Namef j Requestor e mailf Get Security Code Cancel Fig 2 Get Security Code Screen 2 Complete both fields which are mandatory The e mail should be accurate so that the e mail with the security code is sent to the correct recipient 3 When the fields have been correctly completed press the Get Security Code link and a
4. be displayed at the top of the form when the link Get EudraCT Number is pressed Any combination of the following warning messages may appear depending on which fields have not been correctly completed Get EudraCT Number All fields marked with must be completed in all requests If you are requesting the EudraCT number as an individual then you may leave the Requestor s organisation name empty In this case the system will copy your Requestor s name into the Requestor s organisation name box You must include your contact details in the Requestor s organisation town city and Requestor s organisation country boxes When you have completed the form press the Get EudracT Number button and an e mail with a EudracT Number will be sent to the e mail address entered If you want to cancel this application for a EudracT number press the Cancel button which will take you back to the main menu The Requestor s organisation town city is required The Reguestor s organisation country is required The Sponsor s protocol code number is required The Requestor name is required The E mail to which the EudraCT number will be sent is required The Security Code is required Requestor s organisation name Requestor s organisation town city Requestor s organisation country Sponsor s protocol code numberf Requestor name E mail to which the EudraCT number will be sent zt Enter
5. confirmation screen will appear The e mail will arrive shortly afterwards depending on network traffic etc Get Security Code Success An e mail has been sent to martin gregory emea eu int with the details Fig 3 Get Security Code Success Screen 1995 2004 EMEA Page 6 of 19 Doc id Eudra C T EUDRACT USER MANUAL GET EUDRACT NUMBER A 4 Check the e mail address printed on this confirmation screen to be sure that it does not contain any typing errors If the e mail address is incorrect then the e mail cannot be delivered See section 5 3 2 Entering an invalid e mail format 5 Atthis point press Continue to return to the EudraCT Welcome Screen The e mail that contains the security code will be sent to the e mail address used in the request form 6 Open this e mail account to find the e mail This will be from user EudraC T eudra org and with the subject Application for Security Code 7 Open the message to obtain the Security code Application for Security Code Message Plain Text Unicode UTF 8 File Edit View Insert Format Tools Actions Help Co Reply GV Reply to All W I Forward amp Es L LL x A db AS BR From EudraCT eudra org Sent Fri 05 03 2004 16 25 To Gregory Martin Ge Subject Application for Security Code Nour security code is 12312823 This code will only be valid for 24 hours THIS IS AN AUTOMATED EMAIL PLEASE DO NOT REPLY AS EMAILS RECEIVED A
6. e mail from the EudraCT system will be returned to EudraCT as undeliverable The EudraCT system cannot do any more in this instance and your e mail will not arrive You must make another request for a security code 3 E mail address of another recipient 1995 2004 EMEA Page 8 of 19 Eudra Cy EUDRACT USER MANUAL GET EUDRACT NUMBER Beet If you use another person s e mail and not your own then you will not receive the e mail in your mail account Either contact the other person to check that they have received the e mail with the security code or request a new security code to be sent your own e mail address 5 3 4 Using incorrect navigation keys The standard internet browser keys should not be used to find forms that have been already been submitted If a page that has been submitted once is submitted a second time then the following error message will appear Resubmit Data Error You have attempted to resubmit data by using either the browser back button or refresh option Press Continue to continue do not use the Browser Back Button Fig 7 Resubmit Data Error Screen This error is corrected by taking the Continue link which returns to the EudraCT Welcome screen From here the appropriate link can be used to obtain a security code 9 3 5 Unexplained processing errors There are situations that may cause the application to fail that are out of the control of the application environment When such a s
7. mail e Enter the security code sent earlier Enter here the EudraCT security code obtained by using the Get Security Code link This security must not have been used on another application and it must be less than 24 hours since it was issued e Please select the Member States where it is anticipated that the trial will be run This is not mandatory information but completion will provide some advanced indication of likely Clinical Trial applications in each Member State The Member States selected will represent the best available information and may change However should this information change there is no requirement to notify any Member States of the changes 3 When the fields have been correctly completed you should press the Get EudraCT Number link and a confirmation screen will appear The e mail will arrive shortly afterwards depending on the speed of your local e mail servers Get EudracCT Number Success An e mail has been sent to martin gregory emead eu int with the details Fig 10 Get EudraCT Number Success Screen 4 Check the e mail address printed on this confirmation screen to be sure that it does not contain any typing errors If the e mail address is incorrect then the e mail cannot be delivered See section 5 3 2 Entering an invalid e mail format 5 At this point press Continue to return to the EudraCT Welcome Screen The e mail that contains the EudraCT Number will be sent to the e
8. mail address used in the request form 6 Open this e mail account to find the e mail This will be from user EudraC Il eudra org and with the subject Application for EudraCT Number 7 Open the message to obtain the EudraCT Number 1995 2004 EMEA Page 11 of 19 Doc id FEudra G T EUDRACT USER MANUAL GET EUDRACT NUMBER FUD134 v1 0 Application for EudraCT Number Message Plain Text Unicode UTF 8 File Edit view Insert Format Tools Actions Help Ge Reply E Reply to All W Forward L E x AA we AS H From EudraCT eudra org Sent Wed 10 03 2004 12 51 To Gregory Martin KS Subject Application For EudraCT Number The EudraCT number 2004 000249 40 has been issued for your Sponsor s Protocol Code Number protocol 1245 THIS IS AN AUTOMATED EMAIL PLEASE DO NOT REPLY AS EMAILS RECEIVED AT THIS ADDRESS WILL BE AUTOMATICALLY DELETED Fig 11 EudraCT Number e mail This e mail also includes the Sponsor Protocol Code Number for this request 8 Save this e mail It is the receipt of confirmation of EudraCT number required as one of the documents to be included in the request for the Clinical Trial 1995 2004 EMEA Page 12 of 19 Eudra Cy EUDRACT USER MANUAL GET EUDRACT NUMBER Hips a 6 3 Problems that may be encountered 6 3 1 Not entering mandatory data Most of the fields on the Ger EudraCT Number screen are mandatory If an entry is omitted then an appropriate error message will
9. ACT NUMBER Hips a There are situations that may cause the application to fail that are out of the control of the application environment When such a situation occurs the error screen will be displayed Press the OK link to return to the EudraCT Welcome screen To prevent further errors it advisable to exit your internet browser restart it and re enter the EudraCT system from the main link on the Eudra home page See section 4 1 Access to the EudraCT System Such errors should be reported to the system administrators by e mail using the contact link on the EudraCT Welcome screen e There has been a technical error processing this request Please use the contact action in the Banner if you wish to report the problem You may need to restart your Browser if you encounter further problems Fig 16 EudraCT Technical Error Processing screen 1995 2004 EMEA Page 17 of 19 Eudra C EupraCT User MANUAL GET EUDRACT NUMBER 7 GLOSSARY OF TERMS MSCA Member State Competent Authority MS Member State XML The data format of the saved CT Application Form information EC Ethics Committee 8 SUMMARY OF SYSTEM ERROR MESSAGES Message Screen Correction Requestor name is required Get Security Code Enter correct information or cancel Doc id EUD134 v1 0 Requestor e mail is required Get Security Code Enter correct information or cancel Requestor s e mail Address Get EudraCT Number or cancel You have
10. Eudra T EUDRACT USER MANUAL GET EUDRACT NUMBER Hips a EUDRACT USER MANUAL GET EUDRACT NUMBER Reference EUD134 Version 1 0 Date March 2004 1995 2004 EMEA Page 1 of 19 Eudra T EUDRACT USER MANUAL GET EUDRACT NUMBER Hips a CONTENTS E ABOUT THIS DOCUMEN cise scsoac ek sconce ccna E E EE EE E A 3 2 CN NENG NA H E 3 2 1 BE E EE 3 2 1 1 Eege 3 2 1 2 GER 3 IN HEN A ass a sesh i ssc aos sass Se seme thence cence can ecestc ce seact ee cecected nace case ceztcaeccactessece 3 3 1 SYSTEM REQUIREMENT EE 3 3 1 1 I EE 3 SBS EE hee 3 K PPO SS CO nee atc aca mcs cea nce mcd daa ea ese ed angen Reet E ated 3 A ACCESSING RH ate a LEM eas E RE AE EE E E N 4 AL ACCESS TOTEEODRACI SYS T Meese i E E A EE E E ane 4 A NAVATO TIES EE 4 Ar PEER Ee E CT ECCOME TAO oprea a Ea E E E 4 5 REQUESTING A EUDRACT SECURITY CODE cccssssssssssssssssssssssssssssssssssssssssccssssssssssssssssssssssssssssssssssees 6 5 1 PINRO EN EE 6 5 2 FERREIRA 6 5 3 EREECHEN 7 5 3 1 INO CNICTING mandaly GONG E 7 5 3 2 Entering an invalid e mail J OVINE ege K KEE Not receiving the e mail K 5 3 4 EE EE 9 53 0 EE DV OCCS SUVS CHV EE 9 6 REOURSTING A EUDRACT NUMBER sececcccsecescccscescsccssecwccceseewcccasesecececeenccasancuscseaccesusseccusseessecesueeccesceessccsstess 10 6 1 EREECHEN eegen 10 6 2 THE PROCESS FOR OBTAINING A EUDRAC TD NUMBER soioscceiscewsscieten veeendussdeheserse acunnecheaedwyaln ceaneetesessactneevieieaest 10 AS PROBLEMS THAT MAY
11. EudracT Number security Code 61310654 has expired You must apply for a new one THIS IS AN AUTOMATED EMAIL PLEASE DO NOT REPLY AS EMAILS RECEIVED AT THIS ADDRESS WILL BE AUTOMATICALLY DELETED Fig 17 Expired security code e mail 1995 2004 EMEA Page 15 of 19 Eudra EUDRACT USER MANUAL GET EUDRACT NUMBER Hips aa 6 3 7 Using a security code more than once Security codes are only valid for one EudraCT Number request If the security code is used more than once then the following error will be received when the Get EudraCT Number link is taken The security code has already been used in a request for a EudraCT number Please check the security code and if necessary request a new one An e mail has been sent to lt e mail address gt with this information Fug 16 Duplicate security code error message An e mail will be sent to the e mail address on the EudraCT Number request form so that there is a positive record that a EudraCT number has not been issued for the request Application for EudraCT Number Message Plain Text Unicode UTF 8 Eile Edit View Insert Format Tools Actions Help Eo Reply GV Reply to All W I Forward amp 5 L LL x t p RR From EudraCT eudra org Sent Fri 12 03 2004 10 25 To Gregory Martin Egi Subject Application for EudraCT Number Security Code 10983786 already used THIS IS AN AUTOMATED EMAIL PLEASE DO NOT REPLY AS EMAIL
12. M Get EudraCT Number Cancel Fig 9 Get EudraCT Number Screen OOOOOOOO0OO OOOOOOOOO OOOOOAOOAOO 1995 2004 EMEA Page 10 of 19 Doc id Eudra Cy EUDRACT USER MANUAL GET EUDRACT NUMBER BroeesecH 2 The requestor will complete all the mandatory fields which are marked with e Requestor s Organisation Name Include in here the name of the organisation that the requestor works for If the requestor is not making the request on behalf of an organisation but on their own behalf then the Requestor s Organisation Name should be left blank but you should use the fields Requestor s Organisation Town City and Requestor s Organisation Country to enter your own Town or City and Country respectively e Requestor s Organisation Town City This is a mandatory field e Requestors organisation Country This is a mandatory field Select the appropriate country from the drop down list of all the countries of the world e Sponsor s Protocol Code Number This is the Protocol Code Number for the clinical trial that will be linked to the EudraCT number obtained from this request It can be entered in the normal format used by the requestor s organisation e Requestor name Enter your name e E mail to which the EudraCT Number will be sent Enter the e mail address to which the EudraCT Number should be sent Any valid e mail address is acceptable and need not be the requestor s e
13. S RECEIVED AT THIS ADDRESS WILL BE AUTOMATICALLY DELETED Fig 17 Duplicate security code e mail To correct this error 1 Take the Cancel link on the Get EudraCT Number page to return to the EudraCT Welcome screen and request a new security code to be used in a new EudraCT Number request 6 3 8 Using incorrect navigation keys The standard internet browser keys should not be used to find forms that have been already been submitted If a page that has been submitted once is submitted a second time then the following error message will appear Resubmit Data Error You have attempted to resubmit data by using either the browser back button or refresh option Press Continue to continue do not use the Browser Back Button Fig 15 Resubmit Data Error Screen This error is corrected by taking the Continue link which returns to the EudraCT Welcome screen From here the appropriate link can be used to obtain a security code If the browser back key is used to find an earlier screen used to submit a request for a EudraCT then on the resubmit of the screen there is likely to be additional revalidation of the submitted data which may result in duplicate Sponsor s Protocol Code Number warnings which should be dealt with in accordance with section 6 3 4 Duplicate Sponsor s Protocol Code Number 6 3 9 Unexplained processing errors 1995 2004 EMEA Page 16 of 19 Eudra Cy EUDRACT USER MANUAL GET EUDR
14. T THIS ADDRESS WILL BE AUTOMATICALLY DELETED Fig 4 Security Code e mail 8 Make a note of the security code for use in your request for a Eudract number The security code can be also be selected and copied from the e mail for pasting into the EudraCT Number request form 5 3 Problems that may be encountered 5 3 1 Not entering mandatory data The two fields on the Get Security Code Screen are mandatory If an entry is omitted then an appropriate error message will be displayed at the top of the form when the link Get Security Code is pressed Either or both of the warning messages shown on the following will be seen if the relevant fields are not completed 1995 2004 EMEA Page 7 of 19 Doc id Eudra C T EUDRACT USER MANUAL GET EUDRACT NUMBER A Get Security Code Fields marked with must be completed ae When you have completed the form press the Get Security Code button and an e mail with a en press the Cancel button which will return you to the main menu e The Requestor Name is required e The Requestor e mail is required Requestor Namef Requestor e mailf Get Security Code Cancel Fig 5 Get Security Code warning messages To correct the error either 1 Enter valid information in the fields identified in the error message s and press the Get Security Code link to obtain a security code 2 Take the Cancel link to return to the EudraCT Welcome Screen and if a
15. ain a EudraCT Number please press this link The following screen will appear Get EudracCT Number All fields marked with ST must be completed in all requests If you are requesting the EudraCT number as an individual then you may leave the Requestor s organisation name empty In this case the system will copy your Requestor s name into the Requestors organisation name box You must include your contact details in the Requestor s organisation town city and Requestor s organisation country boxes When you have completed the form press the Get EudracT Number button and an e mail with a EudracT Number willbe sent to the e mail address entered If you want to cancel this application for a EudracT number press the Cancel button which will take you back to the main menu Requestor s organisation name Requestor s organisation tovin city Requestor s organisation country 3 Sponsor s protocol code numberf Requestor name E mail to which the EudraCT number will be sent Enter the security code sent earlier St Please select the Member States where it is anticipated that the trial will be run CYPRUS ESTONIA GERMANY ICELAND LATVIA LUXEMBOURG NORWAY SLOVAKIA SWEDEN BELGIUM DENMARE FRANCE HUNGARY ITALY LITHUANIA NMETHERLANDS PORTUGAL SPAIN AUSTRIA CZECH REPUBLIC FINLAND GREECE IRELAND LIECHTENSTEIN MALTA POLAND SLOVENIA UNITED KINGDO
16. attempted to resubmit data Get Security Code Press Continue do not by using either the browser back use the Browser Back button or refresh option Button There has been a technical error Get security code and processing this request Get EudraCT Number town city is required mandatory information country is required mandatory information Number is required mandatory information mandatory information number will be sent is required mandatory information The Security Code is required The Security Code entered must be Get EudraCT number An incorrect security code 8 digits has been used Check the security code provided from the e mail and request a new code if required Unable to find security code Get EudraCT number An incorrect security code has been used Check the security code provided from the e mail and request a new code if required 1995 2004 EMEA Page 18 of 19 Euro Eudract Number has already been Get EudraCT number issued for Protocol Code Number lt Protocol Code Number gt Are you sure that you wish to proceed to generate another EudraCT Number It is likely that a EudraCT Number has already been issued to another individual within your organisation or another collaborator on this trial Please Check whether you have duplicated this EudraCT number request for your clinical trial If you are absolutely sure that you wish to continue then click the Get EudraCT Number button below ot
17. ber has already been issued for Protocol Code Number Prot 123 2004 Are you sure that you wish to proceed to generate another EudraCT number Itis likely that a EudracT number for this Protocol Code Number has already been issued to another individual within your organisation or another collaborator on this trial Please check whether you have duplicated this EudraCT number request for your clinical trial If you are absolutely sure that you wish to continue then click the Get EudraCT Number button below otherwise click the Cancel button Fig 14 Duplicate Sponsor s Protocol Code Message It is very unlikely that different sponsors will use the same Protocol Code Numbers for their trials However this may happen and within the Community it is the EudraCT Number that will provide the truly unique reference to the sponsor s trial If the system detects a duplicate sponsor protocol code number the system will warn the requestor and in this case the most likely explanation is that a EudraCT number has already been requested by someone from the same organisation or another collaborator in the trial The option is given to exit the system without creating a new EudraCT number so that checks within the organisation or trial collaborators can be completed To deal with this warning either 1 Press the cancel button which will return to the Welcome to Eudract screen The appropriate link can then be used to request a EudraCT Number
18. ge 3 of 19 Eudra T EUDRACT USER MANUAL GET EUDRACT NUMBER Hips a 4 ACCESSING THE SYSTEM 4 1 Access to the EudraCT System The EudraCT system is accessed using a link from the EMEA public home page that has the address www emea eu int 4 2 Navigating the system There are certain navigation principles applied to the system In particular e The standard browser navigation buttons Forward and back should NOT be used e Only the navigation buttons on the EudraCT screens should be used The following Navigation keys are used in the system Cancel This link will clear any data that you may have entered on a form and will return you to the EudraCT Welcome Page Get Security Code and Get EudraCT Number These links will submit the appropriate form for processing to obtain the security code or EudraCT number respectively Continue or OK These links are used on information and error message screens and will take you back to the EudraCT Welcome page 4 3 The EudraCT Welcome page This is main index to the EudraCT system and has two links under the following headings Apply for Security Code If you require a security code please press this link Apply for EudraCT Number Once you have the security code and wish to obtain a EudraCT Number please press this link Eudra home page Click here to return to Eudra home page In addition to these system links there are also links for FAQ This is provides a list of frequently asked q
19. herwise click the Cancel button The security code has already been used in a request for a EudraCT number Please check the security code and if necessary request a new one An e mail has been sent to lt e mail address gt with this information The security code has expired An e mail has been sent to lt e mail address gt with this information Get EudraCT number Get EudraCT number 1995 2004 EMEA EUDRACT USER MANUAL GET EUDRACT NUMBER Doc id EUD134 v1 0 Correction Ref Follow the screen instructions Follow the screen instructions Obtain a new security code and make a new request for a EudraCT number Page 19 of 19
20. ication links The e mail may have been sent to a correct e mail recipient but the mail servers are slow or the communications links may have failed The EudraCT system cannot help in this instance You may decide to wait to be sure that the e mail has not will not arrive and then make a new request for a security code 2 Wrongly typed e mail address You may have included an e mail address in the correct format but mistyped the name In this instance the e mail from the EudraCT system will be returned to EudraCT as undeliverable The EudraCT system cannot do any more in this instance and your e mail will not arrive You must make another request for a security code 3 E mail address of another recipient If you use another person s e mail and not your own then you will not receive the e mail in your mail account Either contact the other person to check that they have received the e mail with the security code or request a new security code to be sent your own e mail address 6 3 4 Duplicate Sponsor s Protocol Code Number The EudraCT system will check that the Sponsor s Protocol Code Number submitted on the form is unique within the EudraCT database It is very unlikely that different sponsors will use the same Protocol Code Numbers for their trials However it may be that the Sponsor s protocol Code Number submitted already exists and then a warning message is displayed when the Get EudraCT Number link is taken e A EudraCT Num
21. identifies some simple information about the requestor and the Sponsor s Protocol Code Number of the trial for which the EudraCT number is required There are two simple forms to collect the information required and the security code and EudraCT number will be returned by e mail 2 1 1 Entering Data The system is based on web enabled request forms These collect the information required for the request of a security code and EudraCT Number and provide the results as e mail messages The data entry fields have pre determined lengths and it is not possible to enter data in excess of these 2 1 2 Saving and Printing The data entered on the web pages can be saved by saving the web page The information returned as e mails can be saved and printed from within the e mail system 3 GETTING STARTED 3 1 System Requirements 3 1 1 E mail requirement To operate the EudraCT system you will need to have a current e mail account and have software on your PC that enables you to receive e mails 3 1 2 Browser requirement The system operates most effectively using Microsoft Internet Explorer v5 and above 3 1 3 PC specification There is no special set up required Your PC should ideally be set to use Internet Explorer v5 or higher and the screens are best viewed at a screen resolution of 1024x768 All pages that are larger than the screen view will scroll so that all the information on a page can be viewed at any screen resolution 1995 2004 EMEA Pa
22. ink is taken depending on the particular situation e The Security Code entered must be 8 digits e Unable to find security code Fig 15 Security Code Error Messages To correcting the error depends on the reason for the failure 1 If the security code had been incorrectly typed then enter the correct code and take the Get EudraCT Number link 2 Ifthe security code is incorrect then press the Cancel link to return to the EudraCT Welcome page and apply for a new security code 6 3 6 Using an expired security If an expired security code is entered then the following messages will appear when the Get EudraCT Number link is taken e The security code has expired An e mail has been sent to lt e mail address gt with this information Fig 16 Expired security code error message An e mail will be sent to the e mail address on the EudraCT Number request form so that there is a positive record that a EudraCT number has not been issued for the request To correct the error 1 Press the Cancel link to return to the EudraCT Welcome page request a new security code and then start the request for the EudraCT Number again Application for EudraCT Number Message Plain Text Unicode UTF 8 Eile Edit view Insert Format Tools Actions Help o Reply Fereply to Al oE Forward d Y DS e e AB From SudraCT eudra org Sent Fri 12 03 2004 12 48 To Gregory Martin Gc Subject Application for
23. ituation occurs the error screen will be displayed Press the OK link to return to the EudraCT Welcome screen To prevent further errors it advisable to exit your internet browser restart it and re enter the EudraCT system from the main link on the Eudra home page See section 4 1 Access to the EudraCT System Such errors should be reported to the system administrators by e mail using the contact link on the EudraCT Welcome screen e There has been a technical error processing this request Please use the contact action in the Banner if you wish to report the problem You may need to restart your Browser if you encounter further problems Fig 8 EudraCT Technical Error Processing screen 1995 2004 EMEA Page 9 of 19 Eudra Cy EUDRACT USER MANUAL GET EUDRACT NUMBER Hips a 6 REQUESTING A EUDRACT NUMBER 6 1 Introduction This part of the system is used to obtain a EudraCT number for the Clinical Trial A EudraCT Number is needed in order to make a successful Clinical Trial Application with Europe Once a EudraCT number has been issued it is to be used as the unique reference for the clinical trial throughout Europe and the use of more than one EudraCT number to describe the same Clinical Trial is prohibited 6 2 The Process for Obtaining a EudraCT Number To obtain a EudraCT Number use the following sequence 1 From the EudraCT Welcome Screen take the link Once you have the security code and wish to obt
24. security code is required take the appropriate link back to the Get Security Code screen 5 3 2 Entering an invalid e mail format The EudraCT system will check to ensure that the e mail address entered complies with the standard format If an e mail address with an incorrect format is entered the following error message will appear on the screen when the Get Security Code link is pressed You have entered an invalid Requestor s e mail address Fig 6 Invalid e mail address format warning To correct the error either 1 Enter an e mail address with a valid format and press the Get Security Code link to obtain a security code 2 Take the Cancel link to return to the EudraCT Welcome Screen and if a security code is required take the appropriate link back to the Get Security Code screen 5 3 3 Not receiving the e mail There may be several reasons why the e mail does not arrive The most commonly occurring are 1 Failure of the e mail system or communication links The e mail may have been sent to a correct e mail recipient but the mail servers are slow or the communications links may have failed The EudraCT system cannot help in this instance You may decide to wait to be sure that the e mail has not will not arrive and then make a new request for a security code 2 Wrongly typed e mail address You may have included an e mail address in the correct format but mistyped the name In this instance the
25. the security code sent earlier zt Fig 12 Get EudraCT number field warnings To correct the error either 1 Enter valid information in the fields identified in the error message s and press the Get Security Code link to obtain a security code 2 Take the Cancel link to return to the EudraCT Welcome Screen and if a EudraCT Number is required take the appropriate link back to the Get EudraCT Number screen 6 3 2 Entering an invalid e mail address format The EudraCT system will check to ensure that the e mail address entered complies with the standard format lf an e mail address with an incorrect format is entered the following error message will appear on the screen when the Get Security Code link is pressed You have entered an invalid Requestor s e mail address 1995 2004 EMEA Page 13 of 19 Doc id Eudra Cy EUDRACT USER MANUAL GET EUDRACT NUMBER BroeesecH Fig 13 Invalid e mail address format warning To correct the error either 1 Enter an e mail address with a valid format and press the Get Security Code link to obtain a security code 2 Take the Cancel link to return to the EudraCT Welcome Screen and if a security code is required take the appropriate link back to the Get Security Code screen 6 3 3 Not receiving the e mail There may be several reasons why the e mail does not arrive The most commonly occurring are 1 Failure of the e mail system or commun
26. uestions Help This link provides on line access to this user manual Contact This link provides the facility to send an e mail to the system support group at 1995 2004 EMEA Page 4 of 19 Eudra EUDRACT USER MANUAL GET EUDRACT NUMBER Beete Welcome to EudracT EudracT Number In order to provide a unique reference for clinical trials with at least one site in the Community each trial will be given a Unique number the EudracT Number which must be included on all Clinical Trial applications within the Community and as needed on other documents relating to the trials e g SUSAR reports Steps 1 and 2 below access the forms that must be submitted in order to obtain a EudracT Number EudraCT Number Step 1 The first stage in the process is to obtain an authenticated security code This security code will be sent to the e mail address specified by you the requestor an the form and is needed in order to complete the EudracT Number request The security code is valid for one EudracT Number only and expires after 24 hours Apply for Security Code EudraCT Number Step 2 This is the main EudracCT Number request that allows the requestor to obtain a EudracT Number that Will provide the unique reference for the Clinical Trial The EudracT number will be sent to the e mail address specified by you the requestor on the form Apply for EudraCT Number Return to EudraCT Home Page Fig 1 EudraCT Welcome Screen 1995 2004
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