Table of Contents, Summaries of Database Management Systems (DBMS)

Download Table of Contents and more Summaries Database Management Systems (DBMS) in PDF only on Docsity! Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 1 Welcome to the Data Entry System User’s Manual. This manual will cover all of the steps necessary for you to successfully navigate and operate the Data Management Unit’s Web based data entry system. We ask that you please keep this manual readily available at all times when using the system so that in the event that a question arises you will be prepared. In the event that questions arise which are not addressed in this manual, we ask that you immediately contact the Data Management Unit, at either the e-mail or phone numbers listed in Appendix I of this manual. Table of Contents System Security and User Access…………………………………………. 2 System Requirements …………………………………………………….. 2 Safeguards in the Event of System Failure ……………………………….. 3 Passwords ………………………………………………………………… 3 Study Design ……………………………………………………………… 4 Accessing DMU Web Site and Data Entry System ………………………. 5 Selecting a Study …………………………………………………………. 7 Entering Study Header Information ……………………………………… 8 Schedule ………………………………………………………………….. 9 Data Collection (Researcher)……………………………………………… 10 Form and Field Validation ………………………………………... 11 Submitting Data ………………………………………………….. 13 Data Collection (Patient/Self Administered)………………………………. 15 First Quality Assurance Check ……………………………………………. 18 Logging Off the Data Entry System ……………………………………… 20 Record Locking …………………………………………………………… 22 Quality Assurance System ………………………………………………… 22 Updating ………………………………………………………………….. 26 Overview of Printing………………………………………………………. 26 Study Summary …………………..……………………………………….. 27 Reviewing From the Subject Progress Report…………………………….. 29 Reviewing From the Schedule ……………………………………………. 30 Subject Summary …………………..……………………………………... 32 Printable Report…………………..……………………………………….. 33 Administrative Menu …………………………………………………….. 34 Special Instruments ………………………………………………………. 38 Visual Analog Scales….…………………………………………... 38 Continuous forms………………………………………………….. 39 Appendix I – Contact Information ……………………………………… A-1 Appendix II – Minimum System Requirements ………………………….. A-2 Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 2 In order to successfully and efficiently utilize the web based data entry system, a few key procedural issues must be addressed. Specifically; system security and user access, meeting minimum system requirements, safeguards in the event of system failure, passwords, and study design. System Security and User Access System security is maintained through the use of a double authentication system. What this means is that a system user is assigned two username/password combinations. The first is the one selected by the registered user and provides access to the main Data Management Web Site. Access to the web site is limited to authorized users by the following condition: All users must become registered with the Data Management Unit (DMU). To register for access to the web site please use the following URL: http://dmu.trc.upenn.edu/register. Access to the Data Management Unit’s Web Site must be approved by the Director of DMU and the Senior IT Project Manager. The second username and password is assigned by the DMU, and provides access to the data entry portion of the web site. Strict standards are enforced when providing access to the data entry system. Users are only assigned to designated studies within the web entry system, and only the Study PI can authorize this assignment. The Study PI will validate users in writing for access and security assignment. If you do not have access to a specific study within the data entry system, and feel you should, please contact the Study PI. Additionally, all users of the Web data entry system must complete the Data Management Unit’s training and certification. User Names and Passwords will only be assigned to certified individuals. Please contact DMU for the data entry training schedule. In order to maintain system security users must adhere to the procedures detailed in Logging off the Data Entry System (pg 20). The Data Management Unit will not be accountable for the improper use of any user account. In the event that your account becomes compromised please inform the DMU immediately. If the DMU notices unusual behavior associated with a user account, the account will be suspended and the user will be notified. System Requirements Minimum system requirements have been established by the Data Management Unit as an effective means of limiting technical problems associated with older incompatible systems. The DMU has spent a significant amount of time evaluating both PC and Macintosh based systems and browser technologies available for both. The minimum system requirements are based on these evaluations and are continually updated to include recent developments. (See Minimum System Requirements, Appendix II). The Data Management Unit cannot guarantee the stability or functionality of the entry system for those users attempting to access the system without meeting the minimum system requirements, nor can the DMU take responsibility for issues associated with a client’s Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 5 • Select the Correct Study Assignment • Enter Study Header Information • Collect Data • Handle Exceptions, Form Validation, and Field Validation • Submit Study Data • Print Study Data • Review Study Data • Modify Study Data • QA Study Data • Exit the Data Entry System • Contact the Data Management Unit Accessing DMU Web Site and Data Entry System To successfully access the data entry portion of the web site, you must first access the main Data Management web site. You cannot go directly to the data entry URL, as you will be redirected to the main web site to log in. To log into the main web site enter the following URL into your browser address bar: http://dmu.trc.upenn.edu/dmumain Figure 1 Next enter the usercode and password that you selected during the registration process (Figure 1). If you forgot your usercode or password, you can click on the link: Forgot your usercode or password (Figure 1), that will lead you to a page where you can enter your full name and submit a request for password retrieval. An email will be sent to DMU requesting your login information, we will send the information back to you using the email address you provided to us during your initial registration. Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 6 Once you have successfully entered your usercode and password, you will be redirected to the Homepage of the Data Management Unit web site (Figure 2). Figure 2 From here you will see the link titled “Data Entry System”. Clicking this will display another login dialog box (Figure 3). Figure 3 Enter the User Name and Password assigned to you from the Data Management Unit. DO NOT select the option to “SAVE THIS PASSWORD IN YOUR PASSWORD LIST”. Enabling this option could possibly allow unauthorized users to gain access to the Data Entry System. Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 7 Selecting a Study Once you have successfully entered your data entry username and password, you will be presented with a list of studies that you currently have access to (Figure 4). Figure 4 From this page you can select the study for which you would like to begin entering data, or you can select the link that will return you to the main web site. The Test Study link can be accessed to practice entering instruments as well as getting yourself familiar with our system. Please do not use the real study to practice, that will mix your testing data with the real data already collected. To select a study and begin the entry process, simply click on the study name (Figure 4). Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 10 The schedule of assessments also provides a means of tracking the current status of a subject. As you can see from Figure 7, the color legend tracks the progress of each instrument in the assessment period. If the background color is: • WHITE, data has not been entered. • GREEN, data has been entered. The instrument can still be edited through this link before QA1 is done (See Updating pg 26). After QA1, the instrument can only be reviewed through the instrument name link (See Reviewing From the Schedule pg 30). Please note that the instrument can still be modified in QA2 or Final QA. In this example, QA2 is checked before QA1 is done, that’s because for this study, QA2 is not required, once you submit the data, QA2 will be automatically checked for you, so that you do not need to do QA2. • RED WITH LINK, entry and QA have been completed and the data archived; the instrument cannot be modified. Please note that the instrument can still be reviewed through this link. • RED W/O LINK, the instrument is marked as missing. (See Marked as missing pg 36). You will also note three boxes to the right of each assessment under the headings QA1, QA2, and Final QA. Each box represents a QA operation; once that QA operation has been performed a red check mark will appear. The QA process will be detailed later in this manual (See Quality Assurance System, pg 22). Data Collection (Researcher) To begin entering an instrument, simply click on the instrument name in the schedule (Figure 7). Instruments will be presented to you in Adobe Acrobat format (Figure 8); which is identical to the paper and pencil version with the exception of the data entry fields, and control buttons. Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 11 Figure 8 To begin entering the assessment, simply click within the field of the first question. Next type the response, then hit the tab key to move to the next question. Continue until you have completed the assessment. Form and Field Validation In the event that field validation is triggered, a dialog box will appear alerting you to the error. The dialog box will also provide you with the acceptable valid responses for that field (Figure 9). Figure 9 Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 12 To close the alert, simply click the OK button. You will be returned to the question on the instrument where the validation occurred. To continue simply enter a new value which meets the field validation requirements, then hit the tab key. You may also experience form validation (Figure 10). This differs from field validation in that the alert occurs because of values within two or more fields. To correct form validation errors you have the option of changing any values within the validation fields to produce a valid combination. Figure 10 To close the alert, simply click the OK button. To continue simply enter a new value in one (or both) of the fields which meets the form validation requirements. After correcting, hit the tab key to continue on with the instrument. Form validation may also be triggered when submitting data (See Submitting Data, pg 13). Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 15 Data Collection (Patient/Self-Administered) To begin a patient instrument, the technician will be required to prepare the instrument for data entry. The technician must login to the Data Entry System, select the appropriate study, and enter the appropriate header information for that particular subject. Enter Patient forms continuously: For patient/self-administered instruments, you have the option of allowing the patient to enter the instruments continuously. This option can be added to any study upon request. Below are the details on how continuous patient form administration differs from normal patient form administration (See Figure 15). Figure 15 If the “Enter Patient forms continuously” checkbox is not checked, then the patient administered instruments will be entered exactly like the researcher administered instruments (see pg10). If the “Enter Patient forms continuously” checkbox is checked, then the patient administered instruments will be presented one by one once the header information has been collected and submitted. (See Figure 16). Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 16 Figure 16 Clicking on the instrument name, will be opening the instrument in Adobe Acrobat format, the same format as the researcher administered instruments, the only difference is the navigation buttons at the bottom of the page, only the Submit Data button is present. The Reset Form, Print Form and Return to Schedule buttons are not shown (Figure 17). Figure 17 Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 17 After clicking on the Submit Data button, the patient will be presented with a link to the next patient instrument to be administered (See Figure 18) Figure 18 The patient will need to enter the forms one by one until they have finished entering all the forms for the time period selected in the header. Once all of the patient forms have been administered, the patient will see a screen telling them they have finished entering all the patient forms (See figure 19). From here they can return to header page. Figure 19 Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 20 Selecting Fill out another form from the confirmation screen will take you back to the schedule for the current client (Figure 14, pg 14). From the schedule you can select the next instrument you wish to administer during the interview process. Selecting Go Back to QA page will return you to the Quality Assurance (QA) System; this is detailed in Quality Assurance System (See pg 22) of this manual. Selecting Return to Header will return you to the header page; you can enter data for a different client or the same client with a different time period. Logging off the Data Entry System Once you have completed operations within the Date Entry System, you are required to properly log off the system. It is very important that you log off the system properly so that your account is closed and not active. An account left open would be available for use by someone other than you. To log off, simply close your web browser application within any screen except an open instrument. For more information on operating systems and Internet browsers see the Minimum System Requirements, Appendix II For Internet Explorer (IE) PC users log off can be performed by clicking either the button in the upper right corner or the program icon at the left corner. You may also select the File, then Close option from the drop down menu (Figure 24). Figure 24: PC Internet Explorer (IE) Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 21 For Firefox PC users log off can be performed by clicking the button in the upper right corner. You may also select the File, then Exit option from the drop down menu (Figure 25). Figure 25: PC Firefox For Safari MAC users log off is performed by clicking the Safari, then Quite Safari option only (Figure 26). Clicking the in the upper left corner or the or buttons in the upper right corner on Macintosh systems do not close the browser application. Figure 26: MAC Safari Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 22 Record Locking As mentioned earlier you can close the browser application in any screen to logoff except an open instrument. If you close the browser within an instrument it will become inaccessible for approximately two hours, this is because all records are locked during the data entry process to insure data integrity. A record is a subject’s instrument, within a time period. When you begin the data entry process the record is locked, when you complete the process the record is released, this prevents other users from accessing the record you are currently working with. If you close your browser during this process the record does not get released until a series of cleanup routines determine that the record has been abandoned. Figure 27 If you logged off incorrectly, or another user attempts to access a record currently in use, a Record Lock Error Screen will appear (Figure 27). Quality Assurance System The Quality Assurance System is a system of data checks that must be performed on a record. Individual users are assigned QA rights by the study investigator (See System Security and User Access, pg 2). The QA system has three components; First Quality Assurance Check (QA1), Second Quality Assurance Check (QA2), and Final Quality Assurance Check (Final QA). A record progresses within the QA system after each check is performed. Some studies only need two Quality Assurance checks (QA1 and FQA), some studies only need one Quality Assurance check (QA1 only or FQA only). QA1 is limited to the individual users that performed the original administration of the instrument with the exception of the continuous forms (See pg 39). QA1 will appear in the QA system only if the check was not performed within the Data Entry System (See First Quality Assurance Check, pg 18). Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 25 Figure 30 The two other navigation buttons on this page perform the following functions: Print Form – prints a copy of the instrument with field responses, header information and appended changes. Return to QA List – will return you to the subject list that needs to be QA-ed without submitting any information. The original data, and any pervious modifications will be maintained but the selected QA process and any corrections will still need to be performed. Once you have completed a QA operation and the information has been successfully stored in the Data Management database, a confirmation screen will be displayed (Figure 31). This confirmation screen will inform you of the completion of the QA operation and also contains a table of any fields that were changed during the QA process. This table will also be appended to the Adobe Acrobat version of the instrument. In Figure 31, the modification table shows that no information on the instrument was changed. Figure 31 From the confirmation screen you have three options. “Pick another Form for this Subject to …” will continue the selected QA process with the same subject. (Note: this would be “Pick another Subject for this form to …” if grouped by form). “Pick another Subject to …” you can pick a different subject for the selected QA process. Go Back to QA Page will return the users to the QA Page (Figure 28). Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 26 You can log off the QA system at any time by following the same procedures outlined in Logging off the Data Entry System (See pg 20). The remainder of this document contains information related to the Data Entry System or special features of the system. Updating Updating is a process whereby the user that has collected the instrument can correct information before the QA process begins. Updating can only be performed by the user that collected the information with the exception of continuous forms (see pg 39). To update a record simply select the instrument from the Schedule, make any necessary corrections, then click the Update button on the bottom of the instrument. Overview of Printing Among the navigation buttons on the bottom of every Adobe Acrobat instrument will be the “Print Form” option. Throughout the manual you have seen reference to the “Print Form” button. When using the system you can print the instrument at any point during the entry process, but note that there are some key differences to the resulting print-out depending on what portion of the system you are in. Prior to submitting data to the Data Management database the print-out will only contain the instrument. All print-outs created after data has been submitted to the Data Management Unit will contain a header appended to the top containing all study specific identifier information (Figure 32). Figure 32 A Data Management Unit Number will be printed on every page of the instrument in the upper right hand corner. Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 27 Appended to the end of all instruments printed out after initial submission will be a modification table documenting any changes that have occurred to the instrument since the initial submission (Figure 33). Figure 33 Study Summary The study summary provides an easy to use; real-time table formatted view of the study progress. This information is presented in a drill down format allowing for a global view of study progress displaying overall client population progress. More detailed information regarding a particular subject’s progress within an assessment period can also be obtained. To access the study summary simply click the link Study Summary from the header page (Figure 34). Figure 34 Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 30 Figure 37 Clicking Return to Subject Summary button will return you to the Subject Summary Page (Figure 36) for the current subject. Clicking Print Form button will print the instrument Reviewing From the Schedule Reviewing may also be done at any time from the Schedule (Figure 38), with the exception of a user who has administered an instrument but has not performed QA1 process. In this case, the system will automatically recognize the user and present that user with the updating option. You must be within the Data Entry System or the QA System to obtain a schedule. To access a schedule from outside the system you must select a study, and then have the header information, with the exception of the date field, for the record you wish to review (this information can easily be obtained from the Study Summary, See pg 27.) In the study header you can enter the current date, as this will not overwrite the original data. Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 31 Figure 38 From the Schedule, Simply click on the Instrument Name for the record you would like to review. A read-only copy of the Adobe Acrobat version of the instrument will be returned to you with the header information and the appended modification table (Figure 39). Figure 39 Clicking Return to Schedule button will return you to the schedule for the current subject. Clicking Print button will print the instrument with the data. Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 32 Subject Summary The subject summary provides detailed information about the overall assessment periods, which instruments have been administered, which instruments have not been administered, and which instruments have been marked as missing (see pg 36). To access the subject summary simply click the link Subject Summary from the header page. Clicking the link will lead you to a page where you can select the subject that you would like summary information for from a drop down list of current subjects within the system (Figure 40). After you have selected a subject from the drop-down list you will be led to a page with detailed information about the selected subject. (Figure 41) Figure 40 Figure 41 The first row is the assessment periods within the study, based on the study schedule. The first column contains all the instruments used in the study. Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 35 One of those options is Un-Archive / Header Correction Requests (Figure 45). This option will allow you to either generate an e-mail requesting that a currently archived record (one in which QA1, QA2, and Final QA have been completed), be un-archived, or generate an e-mail requesting that header information for a particular instrument be corrected. Figure 45 Once presented with the screen you have two options, either Unlock Archived Record, or Correct Header Information. If you select Unlock Archived Record, you must enter the Subject Number/Identifier; select a form from the drop-down list, the original header value, and the reason why the record is being unlocked from archival. If you select to Correct Header Information, you must enter the Subject Number/Identifier, select a form from the drop-down list, the original header value, and the corrected header value. Once you make your selection and fill in the appropriate sections you can click the submit button. This will generate an e-mail that will be sent to the Data Management Unit staff. After the Data Management Unit staff validates the information, the request will be processed and a confirmation sent back to you once the requested update(s) have been made. You can also click the Reset button that will clear out all field information, allowing you to start over. Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 36 Another option of the administrative menu is the Missing Forms link where you can mark forms as missing. This option would be used if you did not collect information pertaining to an instrument for a particular assessment period; you would want to mark those forms as missing in the system. To do this, click on the link Missing Forms from the administration page (Figure 44), that will lead you to a page where you can select the subject you want to mark the missing forms for. (Figure 46) Figure 46 After you pick the subject from the drop down list, a page with all the missing forms for that subject is presented to you grouped by assessment periods (Figure 47). From here you can check the instruments under the assessment period(s) that you want to mark as missing. To complete the process scroll to the bottom of the page and click on the submit button. Once forms have been marked as missing in the system you will no longer be able to select them for data entry. Figure 47 Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 37 There are other reports within the system from which you can get additional information about QA1 and FQA status (Figure 48). Figure 48 Special Instruments This section details a few instruments that do not fit the normal form format: Visual Analog Scales and Continuous forms. Visual Analog Scale: An example of the visual analog scale can be found on the CSSA instrument, this assessment combines a patient administered visual analog scale portion with a technician administered portion. For this instrument the patients is presented with the self-administered VAS questions in html format first (Figure 49). Figure 49 Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 40 Figure 52 To resume data collection the next time the patient comes in, login to the data entry system, click on the VNIC study (in this example), and complete the header screen. Here you would enter the header fields and select week 99, date can be any valid date, it will not overwrite the original entry date, a PDF will open with the header information as the first page, and the second page will be the form with the data that you previously entered (Figure 53). From here you can pick up from the data previously entered (this example would be day 7), and start to enter new data. At the bottom of the form, instead of the Submit button, you will see the Update button. To submit the data, click on the Update button. After submitting the data, the previously and newly entered data will be saved. Figure 53 Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 41 Difference between regular and continuous forms: • You will be able to make changes to previously enter data via the update function, but the changes that you have made won’t be logged and appended to the end of the form. This is different from a regular form where the changes you make during the update process are logged and appended to the end of the form. For the continuous forms, any changes you make before QA1 will not be logged and appended to the end of the form (updating). Changes you make in QA1, QA2 and Final QA will be logged and appended to the end of the form. • The other difference between regular and continuous forms is that for regular forms we only allow the same user who administered the form to perform the update and QA1 operations, where for the continuous form we allow different users to perform the update and QA1. Because the continuous form will be administered over a series of time periods it is possible that the user who initially administered the form might leave so other users can continue with the update and QA1 process. The Extend study separates the continuous forms into a different study called “ExTend Study TLFB and Pill Counts”, some studies group the continuous forms under week 99 in the same study like VNIC, other studies group them under continuous in the same study (Figure 54), other studies do not group them separately, review the instructions at the top of your study header page to know how continuous form are designated (Figure 55). Figure 54 Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 42 Figure 55