Compliance Pack Manual - LKC Technologies, Inc.
Contents
1. SuperUser Analyser Jato o o ia Disabled Change User Role Privileges 7 3 Modify Study Information The SuperUser can modify the study information such as Report Title Institution Name and Address The Test Type and Protocol values will be shown but cannot be changed Version 1 0 Page 19 of 23 GLP GCP Study Infomation x Report Title Electro Retinogram Institution Name LKC Technologies LKC Technologies Address 2 Professional Drive Use Ctr Enter Gaithersburg MD 20879 to add new line Www LKC COM Test Type Standard Electro Retinogram Protocol stderg pro Modify Study Information 7 4 Modify Demographics The EMWin software provides for the collection of demographic data The default demographic data are Patient Name Last First MI Diagnosis m Identification 7 Electrode Type n Sex m Pupils Dilated 7 Birthdate Dark Adapt Time These prompts may not be appropriate for your study You can change the names of the demo graphic data fields using the Modify Demographics option The definitions are stored in a text file C EMWin temp Demographics txt which can also be modified using a text editor Figure 17 shows the Demographics form that is used to rename each of the demographic data fields In the example below the first field in the form which would be labeled Last Name in normal usage will be used to hold Animal ID in this study Figure 18 shows the resul2. Cancel GLP GCP User privileges Version 1 0 Page 12 of 23 Save Selection Allows the user to choose which waveforms to save If disabled the user can only save ALL waveforms Auto Save When enabled data will automatically be saved after each recording and the study will move forward to the next step in the protocol The Auto Save can cause difficulties if you are using an ERG protocol with both dark adapted and light adapted steps Once the last dark adapted step is performed the software will imme diately turn on the background light If you need to repeat the dark adapted step the eye will have already become partially light adapted making it impossible to repeat last the dark adapted step It is strongly recommended that you NOT enable the Auto Save function if you are using an ERG protocol with both scotopic and photopic steps All of the other options on the list of User Privileges are covered in the EPIC or UTAS User Manual please refer to it if needed x Once all users have been added and their roles defined click on Quit The study information win Report Title Electro Retinogram dow will appear figure to the right From the protocol drop Institution Name LKC Technologies down menu select the protocol that will be used during the study LKC Technologies Address All data collected in the database Use CtrlEnter KZ Protessional Dive E aithersburg being created will use the selected
3. 40 10 07 2005 4 ytsau Recording at step 1 16 00 58 10 07 2005 5 ytsau Record stop at CSEMWin Interrupt 16 00 58 10 07 2005 6 ytsau Save to record 1 16 00 58 10 07 2005 7 ytsau Save to record tt 2 16 00 58 10 07 2005 8 ytsau Exit database 16 01 33 10 07 2005 3 ytsau Enter database 16 01 56 10 07 2005 10 ytsau Exit database 16 04 23 10 07 2005 11 ytsau Enter database 16 04 59 10 07 2005 12 ytsau Recording at step 1 16 05 48 10 07 2005 13 ytsau Record stop at CAEMWin Interrupt 16 05 48 10 07 2005 14 ytsau Save to record 3 16 05 48 10 07 2005 15 ytsau Save to record 4 16 05 48 10 07 2005 16 ytsau Exit database 16 22 17 10 07 2005 7 ytsau Select DB at C EMWwin 16 31 32 10 07 2005 18 ytsau Select DB at CAEMWin 16 31 39 10 07 2005 19 ytsau Select DB at C EMwin 16 31 53 10 07 2005 20 ytsau Select DB at CAEMwin 16 43 11 10 07 2005 21 ytsau Report record 3 16 43 40 10 07 2005 b Audit Trail Table 7 2 Modify User s Role A SuperUser can change any user s role and password from the GLP GCP User s Role window the privileges associated with each role can also be changed anytime during the study refer to Section 4 Users cannot be deleted from the user list If a user is to be denied access to the data then his her role should be set to Disabled Version 1 0 Page 18 of 23 GLP GCP User s Role EL xi David Scheraga SuperUser auto Mary Analyser John Viewer Stacia Disabled ne David Scheraga le Superser v
4. 6 1 Using Remote Control in EMWin eee ee ee ee ee ee ee eee etta sesta sette seta asse ease eese setas esten sees 16 Managing GLP GCP database eer erae rh tente rh aeu r ERE e eaa Eel en eae ER da eek a eei anh 17 7 1 Trace Audit e aasar e E ree 18 7 2 Modify Users Ur 18 7 3 Modify Study Information oor rene reo vo rhon teo run Piet avaro Eee ro Ho oo ra ee uU eren re bono asinos tietous sssi 19 7 4 Modify Demographics E 20 Analyzing and Reviewing Data cause op ace RO henna aa eae 22 Creating FepOFIS iu oiii deve ed secu esee Mh ees aub eae Hep eg anale eee u aed oet ab ce stars oso Ua ceo o dp deese Ra te 22 Version 1 1 Page 2 of 23 1 General Information 1 1 Contact Information LKC Technologies Inc Customer Service Support 800 638 7055 US amp Canada 1 301 840 1992 Worldwide 301 330 2237 FAX Email Service LKC com www LKC com 1 2 Symbols The following symbols are used in this manual N Caution Read this section carefully 1 3 Software License The GLP GCP Compliance Pack software is a copyrighted product of LKC Technolo gies Inc and may only be used under the following license agreement The software may be used in conjunction with an LKC UTAS or EPIC system only The purchaser of the UTAS or EPIC system may make one copy of the soft ware for convenience of use provided the LKC copyright notice is preserve
5. GCP mode is exactly the same as non GLP GCP mode Please refer to your EPIC or UTAS Users Manual for more information on how to create reports N All actions in creating reports will be recorded and stored in the audit trail Version 1 0 Page 22 of 23 Notes Version 1 0 Page 23 of 23
6. Uitra Violet Stimulator RedHelper Intensi El Reatttper intensity GL CI Remote Electro Oculogram Q None Present None Present None Present System Setup Next a prompt panel will ask for a key x EM For Windows Version 7 00 Please send the following ID number to support lkc com to request a valid key 4058404185 2147549196 Key LKC Technologies Inc Software Key Prompt The ID number is specific to the computer on which the software is being installed Email the given ID number to support lkc com and a key will be sent to you The key is a text string and looks something like this LKCTECHGGGHRQHSRQOGGHRQHSRQOGGHRQHSRQGG Once you have received the key re start the EMWin software follow the directions in this sec tion to this point and then enter your key in the blank field and click OK EMWin software will return to the Main Menu Quit and restart EMWin to finish the process Once the key is installed successfully the GLP GCP Compliance Pack software is ready to be used Version 1 0 Page 9 of 23 3 3 Operating System and Networking The database containing all of the test results and other information will reside on the computer of your EPIC or UTAS system However it is possible for other computers to access the data over a network A separate license for EMWin and the GLP GCP Compliance Pack software must be purchased for each computer that will access the data Contact LKC Tech
7. paper GLP compliance is required for all non clinical pharmacological and pharmacokinetic studies designed to test drug safety and efficacy and GCP compliance is required for similar clinical studies Additionally FDA mandates that all FDA required records stored in electronic format in place of or in addition to a paper record must be compliant with 21CFR Part 11 LKC Technologies provides this overview and associated Internet links for your convenience Standards change and evolve on a regular basis so you should verify the latest requirements and not rely upon this brief overview as being complete or comprehensive Version 1 0 Page 4 of 23 FDA s guideline for 21 CFR Part 11 stipulates requirements for creating maintaining approv ing archiving retrieving printing and transmitting electronic documentation It provides the first definitive set of guidelines for records security To comply with 21 CFR Part 11 pharma ceutical companies and medical device manufacturers must limit system access to authorized in dividuals 11 10 d In addition they must be able to maintain audit trails for all significant activity and system events 11 10 e It is the foundation for good laboratory clinic practice GLP GCP The provisions of 21 CFR Part 11 can be summarized as follows e Accurate Record Generation 11 10 b e Program Timeouts 11 10 d 11 200 a e Audit Trails 11 10 e e Event Logging 11 10 e 11 3
8. 00 d e Input Checks 11 10 h e Controls for Electronic Signatures 811 200 e Password Expirations 11 300 b LKC Technologies EMWin GLP GCP Compliance Pack is designed to be compliant with the provisions of 21 CFR Part 11 It features restricted user access to the computer verification of users identities device operation and data All the records in the GLP GCP studies are secured so that only the assigned users can access them using LKC s software All the operations for the study are stored to provide an audit trail including the name of the user access date and time action recording analyzing creating reports printing etc 2 2 Will LKC s GLP GCP Compliance Pack Guarantee My Study s Compli ance LKC s GLP GCP Compliance Pack provides a series of safeguards which are necessary for LKC s proprietary EMWin software to be GLP GCP and 21 CFR Part 11 compliant How ever compliance with these principles requires more than just a software package The most recent FDA guidance on application and enforcement of 21 CFR 11 Guidance for Industry Part 11 Electronic Records Electronic Signatures Scope and Application see http www fda gov cder guidance 5667fnl pdf for a copy states that the FDA intends to enforce provisions related to limiting system access to authorized individuals use of operational system checks use of authority checks use of device checks determination that persons who develop main
9. EMWin GLP GCP Compliance Pack User s Manual Version 1 1 April 20 2009 Copyright LKC Technologies Inc 2009 All Rights Reserved CE 0086 m a A NS 06 Table of Contents G n ral Information oae ooa pore Ree eot aa donnent nine Ces dk 3 1 1 Contact M Informatia sses asserisson Sess 3 1 2 Symbols oes cescssssetcdecnccsscssevscsvsnnccosceseuvcesveuscvscteesedscsvencesdusorstecsusessaueessetessensesadutersdaqsevensssueessees 3 1 3 Software License RR 3 G n ral OV CPV CW DN Mm 4 2 1 What are GLP GCP and 21 CFR 11 e eeeeeeee eee etes ette eren ette ette sten seta seta setas ease tna tnae 4 2 2 Will LKC s GLP GCP Compliance Pack Guarantee My Study s Compliance 5 Installing and Enabling the GLP GCP Compliance Pack eee 7 3 1 Installing the SOPtWare sccscscsescsssesscsontesousssessssessvesenassonvsscoosessusesesesscesdes e rs een en eee eee nee Ets ones 7 3 2 Enabling GLP GCP and Entering the Software Key sssssccssssssssssssssccssssscssscesssscssssseees 8 3 3 Operating System and Networking 10 Creating a GLP GCP Database wivisicssceassccsasssssicseisiersdesdivaneccasnicsdedevtuncdesentiuctavtecusnsvenadeseviees 11 Selecting d Database seine fv na eA ORO m er pena el ehe aces 14 Recording data in GLP GCP mode eee eee e ee sees seen eese ere toner tn seta tasse e seen nae 15
10. all EMWIN by going to Start gt Control Panel gt Add Remove Programs Then delete the C EMWIN folder Reinstall EMWIN using the copy that came with your system or contact LKC at support lkc com to acquire the latest EMWIN package Copy your old databases and protocols from C EMWIN_BACKUP into C EMWIN Your data bases have extensions MDB and protocol have extensions UDP Insert the EMWIN software CD into the computer Open CD go to the EMWIN folder and dou ble click on the EMWIN SetUp icon to install EMWIN Version 1 0 Page 7 of 23 3 2 Enabling GLP GCP and Entering the Software Key Open EMWin by double clicking on the EMWin software icon The main menu of EMWin will appear EM for Windows Version 8 1 0 x Reports EMWIN Main Menu From the main menu select Utilities System Setup A warning message will pop up x PN Changing the system setup is not recommended Are you sure you want to continue Click on Yes Another dialogue box will open as shown below In the GLP GCP section change the selection from None to Present and click the OK box Version 1 0 Page 8 of 23 System Setup E EPIC 3000 UTASE3000 EPIC 4000 UTAS E4000 UTAS UTAS With Double Flash None S62002 205 SunBurst BigShot Sine Wave Harmonics None Xenon CHG DD MMIYYYY Print Cursor with Label Pattern Stimulato SunBurst BigShot Options With Labels Mj Save to file None Q CRT LCD
11. art from EMWin main menu and select Utilities Create New Database GLP GCP Database Type in a name for the database and click on Enter The GLP GCP oli Role TRUONG User s Name David Scheraga User s Role SuperUser pop up Figure 7 SPESE Password All Users of the CLP GCP Compliance Pack software must have a Windows account on the LOS The person creating the database is defined as the SuperUser also known Add Modif Set GLP Options as the Administrator The LS ET peret SuperUser s information UserName Password and Role are automatically entered and are those of the SuperUser s Windows account on the computer The SuperUser can change his her EMWin GLP GCP Compliance Pack password by typing a new password in the Password field and clicking the Modify button GLP GCP User s Role The UserName entered for each individual in the GLP GCP Compliance Pack software must N be the same as their Windows user name on the computer Any user names that are not Win Version 1 0 Page 11 of 23 dows users can not login to the GLP GCP study even their names are assigned in the study Only the Administrator can create a new GLP GCP database and assign users and their ini N tial passwords It is recommended that each user should change their password immediately after logging in for the first time The SuperUser must enter the User Name for all other users and set their role For each user the SuperU
12. d with each copy This license specifically prohibits the use of this software on any computer that is not directly connected to an LKC Technologies Inc UTAS or EPIC Interface Unit The software may be used by the purchaser of the UTAS or EPIC system however to produce reports of UTAS or EPIC data using one and only one stand alone computer system LKC warrants only that the software will conform to the specifications described in this manual If the software is determined not to conform to any specification a bug LKC will take measures necessary to cause the software to conform to Version 1 0 Page 3 of 23 specification s bug fix as quickly as is possible in LKC s sole judgment LKC does not warrant this software to be suitable for any specific business purpose nor will LKC be responsible for any incidental or consequential damages associ ated with its use including loss of revenue delay of revenue opportunity or any business impact of associated testing 2 General Overview 2 1 What are GLP GCP and 21 CFR 11 The US Food and Drug Administration FDA regulated industries such as Bio Pharmaceutical Personal Care Products Medical Devices and Food and Beverage are required to document and acknowledge conditions and events during development verification validation and manufac turing of products Most governments now require compliance with GLP and GCP Good Laboratory and Clinical Practice respectively regulations fo
13. ecuting the next command Saving data takes less than 1 second and you may choose to wait for 1 second Step FWD will also take for less than 1 second After then you are ready for the next cycle Therefore you will have 4 seconds in total for one cycle If you want to wait for a longer time before next step you may simply add the seconds to the last command waiting time If your protocol has 10 steps and you want to finish the protocol automatically you need to set Cycle Number to 10 To launch the automation simply click Launch button After all commands are executed the program will present the message All tasks done Click it to acknowledge it You may click Exit to quit the remote panel after then Improper settings of the Remote Control may cause unexpected results Please check your set ting carefully before you launch the Remote Control You must allow sufficient time between commands and steps If your protocol has multiple steps containing variable recording length you need to use the longest one to ensure the recording is completed before the next command is executed The cycle number should be no larger than the total steps Version 1 0 Page 16 of 23 Status 10 30 14 Wait sec ho x Command2 Save Hl Wait2 sec P x Command3 StepFwD x Wait3 sec x Command4 None x Waitd sec z Command5 None x Waitb sec Cycle Number 5 Launch Exit Command Remote contr
14. esses and controls necessary to achieve GLP GCP compliance LKC cannot and does not warrant that your process will be GLP GCP compliant and strongly recommends that you evaluate the underlying functionality of the GLP GCP Compliance Pack software offering to ensure that the functionality provided will allow for compliance in your environment Any claim that your process is GLP GCP compliant is yours and yours alone based upon your analysis and resulting process implementation Version 1 0 Page 6 of 23 This manual often refers to the User s Manual of your EPIC or UTAS system and the EM Win software package We recommend that you keep the two manuals together 3 Installing and Enabling the GLP GCP Compliance Pack If you purchased the GLP GCP Compliance Pack at the same time as your EPIC or UTAS system the software has been pre installed and configured on your computer You can skip this section If you purchased additional licenses of the GLP GCP Compliance Pack for data analysis on additional computers contact LKC Technologies for installation instructions 3 1 Installing the Software You should always back up all of the mdb files in the folder C EMWin before installing the GLP GCP software to avoid the risk of losing your important data Create the first windows User by going into Start gt Control Panel gt User Account Remove the default user account Make a copy of C EMWIN and rename it C EMWIN_BACKUP Uninst
15. haring Properties Then create new Windows account for all the users Log into each newly created account and reinstall EMWIN from their account To maintain patient electrical safety your UTAS or EPIC system must not be connected to a wired local area net work while human patients are being tested Version 1 0 Page 10 of 23 4 Creating a GLP GCP Database There are 3 steps in creating a new GLP GCP database 1 Define the testing protocol 2 Add users and define their roles and privileges 3 Fill in information to be stored and printed Institution Address report title etc The first step in the creation of a study is to create the protocol that will be used EMWin has a number of predefined protocols and will also let you create your own User Defined Protocols UDP Please refer to your EPIC or UTAS Users Manual for instructions on how to create a User Defined Protocol Make sure that you have defined and stored the protocol that will be used for testing or are using a standard protocol supplied with your system before creating the GLP GCP database EPIC UTAS system s computer before they can access a GLP GCP database The User Name in the GLP GCP database must match their Windows User Name ET X corded data and related operation for each study indes J UserName D Roe D Password will be stored in its own David Scheraga SuperUser auto encrypted database To ia oe a create a new database Stacia Disabled logon st
16. n will be changed for non GLP GCP operation of the software until you change the demographic information back again The Birthdate field includes checks to make sure that a valid age or date of birth is entered This is true even if you change the name of this field to something else The format for date of birth may be MM DD YYYY or DD MM YYYY defined in System Setup Age format is either a number or a number followed by a letter d m or y For example 5d indicates 5 days old 2m indicates 2 months old and 10y indicates 10 years old Version 1 0 Page 21 of 23 8 Analyzing and Reviewing Data In order to analyze the data the user will have to select the GLP GCP database of interest and log in Then from the Main Menu select Reports You can narrow your search by entering data in the various search fields If you leave all fields empty all of the data stored in that database can be accessed Patient Information O LLLLLMMMMMMMMMNNMME Animal ID Record Session Po Start Number Po Species Breed I Treatment s Study protocol tt TO Sex Age Age Range To D Years Test Date BM Dther Test Type L me Retrieving Data The array of possible activities of the user depends on its role and associated privileges Refer to the EPIC or UTAS User Manual for more information on the different available functions s mooth print export data 9 Creating reports Creating report in the GLP
17. nologies for more information about installing and using the software on networked computers To allow other users to use the EmWin and GLP GCP compliance pack you must make the C EMWIN a share folder Go to C EMWIN folder and right click select Sharing and Security An EMWIN property window will pop up see figure 7 make sure to select Share this folder on the network and Allow other users to change my files Local Disk C File Edit View Favorites Tools Help e rack EY SB O search Folders ey X Eee o S i EMwin Properties x iz X General Sharing Customize CJ Documents and Settings ol EMwin m Local sharing and security To share this folder with other users of this computer only drag it to the Shared Documents folder C2 Program Files nd WINDOWS To make this folder and its subfolders private so that only you have access select the following check box Make this folder private r Network sharing and security To share this folder with both network users and other users of this computer select the first check box below and type a share name IV Share this folder on the network Share name EMwin IV Allow network users to change my files Learn more about sharing and security i Windows Firewall is configured to allow this folder to be shared with other computers on the network View your Windows Firewall settings Cancel Apply EMWIN Folder S
18. ol dialog panel The setting is an example for auto matic execution of a 5 step ERG protocol 7 Managing a GLP GCP database Only the defined SuperUser can manage the database In order to manage a GLP GCP database you must first select the database refer to Section 5 Then from the Main Menu go to Utilities Manage GLP GCP information The managing option window will appear Manage GLP GCP xj Trace Audit Trail Modify User s Role Modify Study Infomation Modify Demographics Quit Managing GLP GCP database menu The Administrator has four possible activities look at the audit trail modify user roles and privi leges modify the study information and modify the demographics Version 1 0 Page 17 of 23 7 1 Trace Audit Trail The GLP GCP Audit Trail is presented as a table Each entry in the table has an Index number a User Name the Action that the user performed create select save report information about the action and any reason that was given and the date and time of the action This table can be searched by User Name Index Record Step Number Reason or Date The audit trail list can also be printed The printing action itself will be stored in the audit trail GLP GCP Trace Audit Trail x Index UserName Action Record Step User DB Location Reason 1 1 ytsau Create DB at CAEMWin 16 00 08 10 07 2005 2 ytsau Select DB at C NEMWin 16 00 17 10 07 2005 3 ytsau Enter database 16 00
19. r studies demonstrating the safety or efficacy of regulated medical products These regulations require users to prevent electronic data from being improp erly manipulated during the study Internationally the standards for Good Laboratory Practices are maintained by the Organization for Economic Cooperation and Development OECD An index of the relevant guidelines can be found at http www oecd org document 63 0 2340 en 2649 34381 2346175 1 1 1 1 00 html If you are retaining electronic records in compliance with GLP or GCP system design should always provide for the retention of full audit trails to show all changes to the data without ob scuring the original data It should be possible to associate all changes to data with the persons making those changes by use of timed and dated electronic signatures Reasons for change should be given Application of the Principles of GLP to Computerized Systems OECD 1995 If you are retaining electronic records for submission of results to FDA you are required to comply with 21 CFR Part 11 Electronic Records Electronic Signatures US Code of Federal Regulations 1997 These regulations are very similar to the GLP GCP requirements and define the conditions under which the FDA can assure electronic records electronic signatures and handwritten signatures executed to electronic records to be trustworthy reliable and generally equivalent to paper records and handwritten signatures executed on
20. ser enters the User Name and password selects a Role SuperUser Analyzer Viewer or Disabled and clicks on Add While the User Name entered in the GLP GCP database must match their Windows User Name the password can be different from the user s Windows pass word The SuperUser should also ERR sites x determine the privileges associated with each role Options _ SuperUser Analyst Viewer by clicking on the Set GLP Channels Vv Options button the GLP GCP option window Step Backwards M Lj will open Figure 8 and the Step to v SuperUser can select the different privileges that Save Selection M a a he she wants to assign to Auto save different roles Privileges Cursor Placement o E r are enabled by checking the associated box for that user Place a Comment M Vv E type Once finished click Print Iv M Iv OK Manual Reject lv a The first 5 GLP options are oars AR x n specific to GLP GCP Com pliance Pack protocols Smooth v F Channels Allows the user unn Une M E B to change the number of Flick Amp Timing Iv M a recording channels When Invert Iv Iv disabled protocols default to two E channels Hasr ine CONES 3 4 Offline Average Iv Iv Step Backwards Allows a Addwavetarms zi z r user to go to previous step in the protocol ja a Z E Remove Interference Iv M LI Step to Allows the user to jump to any step in the protocol Default
21. tain or use electronic systems have the education training and experience to perform their assigned tasks establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures appropriate controls over systems documentation controls for open systems corresponding to controls for closed systems bulleted above 11 30 Version 1 0 Page 5 of 23 requirements related to electronic signatures e g 11 50 11 70 11 100 11 200 and 11 300 Clearly many of these provisions require the establishment and enforcement of Standard Op erating Procedures and are beyond the ability of any software package to provide compliance The GLP GCP Compliance Pack software provides functionality that when properly imple mented as part of a compliant process will ensure that the correct testing protocols will be fol lowed throughout the course of the study that raw data will be preserved that manipulated data or procedures will be appropriately documented that all records will be properly archived and that access to data can be audited LKC has developed this GLP GCP Compliance Pack software in conjunction with a major pharmaceutical company to be used in their GLP GCP environment LKC believes that this system provides the functionality necessary to achieve GLP GCP compliance when imple mented as a component of a compliant process including all of the necessary business proc
22. ting Patient Information screen as it will appear during testing after the Demographics form has been filled out as shown below Version 1 0 Page 20 of 23 Demographics xj Patient Information Animal ID rr Last Name Animal ID Session First Name Session Species Breed Middle Initial Species Breed iddle Initial Identification Study protocol Age Sex See Birthdate pe Study protocol D 5 5 7 Diagnosis Treatment Group iS Electrode Electrode 0 Treatment HH Pupil Dilated Greu Electrode g ts oni Dark Adapted time Dark adaptation Dark adaptation O Dther me 7 ore Database Database rem Comments Comments For Cursors Ampl Ampl Time Time Cancel Comments Continue Clear Modify Demographics Patient Information Window as it ap pears after Demographics are filled out as in Figure 16 Changes made to the demographic information are first made in the Demographics txt file as noted above When the GLP GCP database is created this information is copied into the data base but also remains in the Demographics txt file Thus If you want to change the demographic information in your GLP GCP studies you must make these changes before you create the GLP GCP database Items related to GLP GCP data collection can not be changed once they are stored in the database After you create the database the demographic informatio
23. tion reasons can be preset by a text file c EMWin jlist txt Click OK button to accept the typed reason or click Cancel button to the step backwards or forwards Version 1 0 Page 15 of 23 iw The reason of the action x SkipStep 1 because Eve blinker nimal moved Eye blinked Prompt for moving back one step in the protocol The recording procedure is similar to recording in a non GLP GCP database refer to your EPIC or UTAS Users Manual for details on how to collect data 6 1 Using Remote Control in EMWin EMWin version 7 0 and above supports automatic execution of protocols This is espe cially useful when you are using a User Defined Protocol with many steps and long intervals be tween steps It is very easy to set up the remote control panel Once the Remote Control is launched the whole protocol will be executed automatically without any manual intervention The Remote Control is selected by clicking Remote menu item in the Perform Tests mode You will see a panel appearing on the upper right corner of the desktop There are a num ber of settings you need to select before you can launch the automation It supports up to five different commands in a cycle Most often you will need Record Save and Step Fwd to achieve one cycle You also need to wait for some time before next command For example if your data acquisition takes 2 seconds you should wait for 2 seconds before ex
24. to add new line WWwWw LKC COM protocol Test Type Standard Electro Retinogram Protocol sdegpo gt stderg pro a kergLEDw pro flickerg pro kflickeraLE D w pro berg pro Study Information Screen If you select a standard protocol provided by LKC the report title and test type fields will be filled out automatically The SuperUser can change these entries by typing in the corresponding field If you select a User Defined Protocol the SuperUser must enter both the report title and the test type Once all information has been entered select the OK button The entered information will be printed at the top of the page of each report The software will then return you to the Main Menu Version 1 0 Page 13 of 23 5 Selecting a Database To use the database you just created it must first be selected From Main Menu go to Utilities Select Database GLP GCP Database choose the correct database from the list and click Open A sign in window will open Enter your User Name and your GLP GCP Compliance Pack pass word and click OK The software will return you to the Main Menu Sign In to GLP GCP x User name Password Cancel Log on Window Version 1 0 Page 14 of 23 6 Recording data in pompam GLP GCP mode Session From the EMWin Main Menu you can start Species Breed testing by selecting Perform Test GLP GCP Study Sex D The patient information windo
25. w will appear ge Figure 11 The minimum information that must be entered in order to proceed is the Study protocol information in the first 4 fields of the form Group O O The default categories are Animal ID Treatment Session Sex Electrode v ERG only Age Dark adaptation Each field has limited length accepting the Other mmm characters The first field such as LastName or AnimalID the second field such as Database FirstName or Session and the third field such as MI or Species are 30 ASCII char acters 15 Unicode characters long mean Comments ing that user can enter the longer names up to 30 characters For the fields of Sex and Age the allowable length is 15 characters Most fields accept up to 30 characters whereas the field Other accepts up to 100 characters and Comments accepts up to 300 characters FFT Y Continue Clear an Patient Information There are certain reserved characters that should not be used to fill in ANY information in the database The reserved characters are _ J There is one main difference between the regular EMWin software and the GLP GCP mode In the GLP GCP mode each time the user saves the waveform the software will automatically go forward to the next step of the protocol If for any reason the user needs to go back a step and record again he she will be asked to enter the reason for his her action Figure 12 The justifica
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