If you are looking for the file of a previously created subject:

1. Select Patients/Patienten in the menu on the left and choose the patient's id from the Patient Overview table or from the menu list of patients. The Patient Overview will automatically list all patients entered at your study site within the last month.
2. If the patient does not appear, change the date in the input fields (From/Von, To/Bis) to the period when the patient was first entered into the database. Then click on the Search/Aktualisieren button.
3. Continue by clicking on the patient’s id in the first column of the table. You will be forwarded directly to the patient’s file.

In order to create a file for a new patient:

1. Choose Patients/Patienten in the menu on the left hand side
2. Click on the sub-menu New patient/Neuer Patient and the Registration eCRF for the new patient appears
3. When the entered data is accepted, clicking Create New Patient/Neuen Patienten anlegen will allocate the next free (3-digit) patient id to the new patient
4. The Eligibility eCRF for the new patient appears

To achieve plausible forms (ie. no mandatory fields are left empty, no implausible values are entered, etc.), fields may be defined as allowing 'exceptions'.
If allowed, a field value exception setting may be:

• normal (ie. none of the following exceptions)
• not applicable/nicht erhebbar
  (eg. foot pulse after foot amputation)
• missing/nicht erhoben
  (eg. information refused)
• not plausible but correct/unplausibel aber richtig
  (eg. patient weighs less than the 50 kg plausibility check)
  (more about 'Not Plausible but Correct Data' in FAQs Data Entry section 4.)
• wrong/falsch
  (eg. measurement device malfunction)

1. Click on the comment/Kommentar "" symbol to the right of the input field
2. A 'Comment ...'/'Kommentar ...' window pops up showing input fields:
   'Comment:'/'Kommentar:' - always
   'State:'/'Zustand:' - only when field allows exceptions
3. The 'State:'/'Zustand:' field allows you to change the value state of the data field to one of the appropriate exception settings in the above list
   eg. set the value as "value is not plausible, but correct"  from the list
4. It is also possible to add a comment in the 'Comment:'/'Kommentar:' field
   
5. Close the 'Comment ...'/'Kommentar ...' window by clicking on the X symbol in its right-upper corner
6. A red exclamation mark "" appears in the eCRF and replaces the comment/Kommentar symbol in order to mark this exceptional value within the eCRF
7. If the state of the input field is changed back to "normal value" the red exclamation mark "" is replaced by the standard comment/Kommentar " "icon
8. Depending on the appropriate field value and exception setting it may now be possible to submit the form without errors

For fields allowing an exception there are different possible reasons for choosing the exception 'not plausible, but correct':

• Data that have been entered were collected accurately but may have been recorded as implausible within the eCRF system (e.g. edit checks of the system are too strict or patient/disease expression is highly exceptional)
• Data that could have been incorrectly recorded in the first instance but can no longer be modified (e.g. patient left or died)
  
• A date is not known completely. For instance, it is possible that only an approximate start date of medication is known, e.g. March 2004, and the exact day is unknown, or the time of a "data and time" field is unknown
• A person is heavier than the maximum weight defined by edit check within the system

In case you would like to further comment the data, a free text can be entered in the 'Comment:'/'Kommentar:' field of the 'Comment ...'/'Kommentar ...' window which can be opened by clicking on the comment/Kommentar " " icon to the right of the input field.

1. Click on the comment/Kommentar " " icon to the right of the input field
2. A 'Comment ...'/'Kommentar ...' window pops up containing the 'Comment:'/'Kommentar:' field.
   The 'Comment:'/'Kommentar:' field allows you to post any text, e.g. reasons for "missing values", specifications on values.
3. Close the 'Comment ...'/'Kommentar ...' window by clicking on the X symbol in its right-upper corner
4. In order to make the presence of a comment visible within the eCRF, the comment/Kommentar " " symbol will be displayed in yellow.

CRF visit states (in the visit bar, to the left of the visit name):

• The patients visit overview bar is shown when the Patient Id is selected from the list of patients or the Patient Overview.
• The icon to the left of the visit name shows the visit status and is usually a synthesis of the statuses of all forms belonging to the visit.

CRF form states (in the form bar of expanded visits, to the left of the form name):

• A transparent box () means that the form has not been submitted yet, it is not yet existent (not existent/nicht angelegt).
• A green box () means that the form is plausible and contains no errors (plausible/plausibel).
• A red box () means that the form contains errors and probably needs revision (editing/in Bearbeitung).
• A seal (red circle with a green addition ) means that the form is signed and cannot be changed. It is ready to be monitored (signed/signiert).
• A light-green check () means that the form has already been signed and is being checked by the monitor (checked/geprüft).
• A dark green check () means that the form has already been signed, and has been checked and closed by the monitor (closed/geschlossen).
• A light-grey box () means that the form has been deactivated (deactivated-rejected/deaktiviert-abgewiesen).

The patients visit overview bar is shown when the Patient Id is selected from the list of patients.
The visit forms overview bar is shown when a visit is selected from the patients visit overview.
The visit forms overview bar displays the name of each visit form, the existing errors in that form, the open monitor queries, the status of the form (plausible, editing, signed, checked, closed and deactivated), the kind of access the currently logged in person has to that form (read, write) and the possible actions for that CRF form.

CRF form actions:

• Investigator: deactivate/deaktivieren a single empty form that is not required for a certain subject in order to document the fact that this form will not be entered.
• Investigator: activate/aktivieren a previously deactivated form to allow data entry (to undo a deactivation).
• Investigator: electronically sign/signieren a form that has been correctly filled out (plausible) and does not need further editing. After signing a form, it is ready for review by the monitor and can no longer be changed unless unsigned.
• Investigator: unsign/designieren a previously signed form to make further changes. This can only only done as long as the monitor has not checked or closed the form. Only the investigator can sign/unsign a form.
  

To finalise a visit, all CRF forms have to be either signed or deactivated.

• Monitor: use check/prüfen to take control of a signed form away from the investigator while monitoring is performed. After monitoring a form may be closed for everyone or returned to investigator control using uncheck.
• Monitor: uncheck/neu prüfen a previously checked form to return control to the investigator eg. for unsign / changes / sign / etc.. This can only be done as long as the monitor has not closed the form. Only the monitor can check/uncheck a form.
  
• Monitor: electronically close/schliessen a checked form after monitoring has successfully checked data accuracy and consistency (database lock). The CRF form cannot be changed afterwards.
  Only data control is authorized to undo the database lock (unclose/öffnen ).

Specifically for 'static' forms (eg. LICHEN Adverse Event and Review):

• Investigator: reject/abweisen to block continuation of the new empty form series.
  (eg. to stop new Adverse Event forms being created after a patient has died)
• Investigator: accept/akzeptieren to remove the block on a previously blocked new empty form series.

After finishing the data entry, a CRF form that doesn’t contain any mistakes needs to be signed by the investigator, so that the data manager/monitor can review the data. In case of any questions about a specific entry, the data manager/monitor sends an online query (system message) to the study site team (create a query). If the visits are done at different study sites it is possible for the data manager/monitor to choose the study site receiving the query.
Once an online query has been sent to a study site, the investigators are informed about new messages in general when logging on to the CTMS and in particular when entering a subject’s eCRF. Both the data manager/monitor and the investigators are responsible for checking, tracking and processing of the queries.
The investigators can finish/Erledigt (query was handled, data modified) or clarify/Nachfragen (query was checked, data not modified) the query. According to the action chosen by the investigator, the data manager/monitor has the option to reopen/erneut öffnen (inquiry checked, disagree or data modification checked, disagree) or to close/schliessen (inquiry checked, agree or data modification checked, agree) the query.
Each closed query will be archived on the message board (Archive/Archiv). An CRF form may only be closed ("locked") when all related queries are closed.
The online message board provides a list of all open queries (Inbox/Posteingang), sent queries (Sent box/Postausgang) and closed queries (Archiv/Archiv) at any time. Total query dialogs are being stored on the message board. From every current or past query, you can easily jump to the respective subject’s CRF form.

An audit trail (change history) is automatically provided and generated for each CRF and input field within the form. The information stored within in audit trail includes

• the person who made the changes,
• when (by showing the date and timestamp/time zone),
• the previous values, and
• new/current values.

This permits the reconstruction of the course of events relating to the creation, modification, and deletion of data. Signing, unsigning, locking and unlocking are trailed as well as general login information (e.g. unsuccessful attempts).
The authentication of the users is assured with a username and password. The audit trail shows the login information of the person that made those changes. The audit trail is viewable and accessible to all users, but its not possible for any user to create, modify, or delete an electronic record and the audit trial attached to it.
The audit trail can be opened by clicking on the symbol on the right-hand side of the input field.

LICHEN Subject/Patient States (to the left of the subject/patient id):

• Undefiniert: a transparent box () to the left of the subject/patient id means that the required pre-randomization criteria (ie. in eCRFs Eligibility, Untersuchungsbefund) are not complete - so randomization is not possible.
• Ausgeschlossen: a red X (X) to the left of the subject/patient id means that the required pre-randomization criteria (ie. in eCRFs Eligibility, Untersuchungsbefund) are not correct - so randomization is not possible.
• Noch nicht randomisiert: a green box () to the left of the subject/patient id means that the required pre-randomization criteria (ie. in eCRFs Eligibility, Untersuchungsbefund) are valid - so randomisation may be attempted.
• Randomisiert: a light-green check () to the left of the subject/patient id means that the randomisation was successfull - so patient treatment/followup may commence according to protocol
  
• Abgebrochen: a red box () to the left of the subject/patient id means that the foreseen patient treatment/followup was cancelled (ie. not completed according to protocol).
  
• Abgeschlossen: a dark green check () to the left of the subject/patient id means that the foreseen patient treatment/followup was completed according to protocol.