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

1. Select "Patients" in the menu on the left or choose the Patient's number in the overview table provided on the Patient list. All patients entered at your study site within the last month will be listed automatically.
2. If the patient does not appear, change the date in the input fields (From, To) to the period when the patient was first entered onto the database. Then click on the Search button.
3. Continue by clicking on the patient’s number in the first column of the table. You will be forwarded directly to the patient’s record.

In order to create a file for a new patient:

1. Choose Patients in the menu on the left hand side
2. Click on the sub-menu New Patient
   
3. Enter patient's personal details
4. Generate a unique pseudonym by clicking on the white arrow to the right of the Patient's pseudonym field
5. Enter patient's personal details in the pseudonymization form and, when complete, click the Creation Pseudonym button.
6. Click Print Pseudonym to print the pseudonymization form for confidential medical documentation
   (Note: printing the form is highly recommended as it is the only way to re-identify the patient's personal data!), and close the form.
   
7. The eCRF for the new patient appears
8. Include the patient by clicking on the Create New Patient button

To obtain valid data, i.e. no mandatory fields are left empty and/or no implausible values are entered, also "missing", "not applicable", "wrong", or " implausible but correct" data must be recorded/defined as such.
A value may be:

• not applicable
• missing
• implausible but correct
• wrong

1. Click on the comment symbol on the right-hand side of the input field
2. A window pops up with one input field: the state field. The sate field allows you to change the state of the data from normal to any exceptional value using a list with several options
3. Define the value as "missing" or "exceptional"  from the list
4. It is also possible to add an additional comment (see chapter 9 "Posting a Comment")
   
5. Close the window by cklicking on the "X" symbol in its right-upper corner
6. A red exclamation mark " " appears in the eCRF and replaces the comment symbol in order to make this exceptional value visible within the eCRF
7. The state of the input field can be changed back to "normal value" everytime
8. The form can then be submitted without errors

There are different reasons for data to be classified as exceptional but not missing:

• 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): implausible but correct
• Data that could have been incorrectly recorded in the first instance but can no longer be modified (e.g. patient left or died): implausible but correct
  
• 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:implausible but correct
• A person is heavier than the maximum weight defined by edit check within the system: implausible but correct

How do handle exceptional data onto the eCRF, see chapter 3 "Missing and Exceptional Values".

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

1. Click on the comment () icon to the right of the input field
2. A 'Comment ...' window pops up containing the Comment: field.
   The Comment: field allows you to post any comment, e.g. reasons for "missing values", specifications on values.
3. Close the 'Comment ...' window by clicking on the (X) symbol in its right-upper corner
4. In order to indicate the presence of a comment within the eCRF, the comment () 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).
• A green box () means that the form is plausible and contains no errors (plausible).
• A red box () means that the form contains errors and needs revision (editing).
• A seal (red circle with a green addition ) means that the form is signed by the investigator and cannot be changed. It is ready to be monitored (signed).
• A light-green check () means that the form has already been signed and is being checked by the monitor (checked).
• A dark green check () means that the form has already been signed, and has been checked and closed by the monitor (closed).
• A light-grey box () means that the form has been deactivated (deactivated / rejected).

The Overview tables for each patient (form overview and visit overview) show the name of the forms and visits, the status of the forms (plausible, erroneous, signed, checked, closed, deleted and deactivated), open monitor queries, 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:

• electronically sign a form that has been correctly filled out (plausible) and does not need further editing. Having signed the form, it is ready for review by the monitor and can no longer be changed unless unsigned. (Usually an investigator action.)
  
• electronically unsign a previously singed form to make further changes. This can only be done as long as the monitor has not checked or closed the form. (Usually an investigator action.)
  
• electronically check a signed form while monitoring process is performedin order to ensure data accuracy. After monitoring, a form cannot be changed afterwards unless unchecked. Only the monitor is authorized to uncheck the form. (Usually a monitor action.)
• electronically uncheck 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. (Usually a monitor action.)
• electronically close a checked form after monitoring process to ensure data accuracy and consistency after monitoring process (database lock). The form cannot be changed afterwards. Only data control is authorized to undo the database lock. (Usually a monitor action.)
  
• electronically deactivate a single empty form that is not required for a certain patient and will consequently not be entered. (Usually an investigator action.)
  
• electronically activate a previously deactivated form to allow data entry (i.e. undo  deactivation). (Usually an investigator action.)
  
• electronically reject the whole sequence of specific forms to block continuation of the empty form series (e.g. all Adverse Event forms). (Usually an investigator action.)
• electronically accept the whole sequence of specific forms that has previously been  rejected in order to allow data entry (undo rejection). (Usually an investigator action.)
• electronically delete the content of a form when it has been submitted accidentially. It is possible to restore the deleted form. (Usually an investigator action.)

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

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

• the person who made the change (by showing name and username),
• when the change was done (by showing the date and timestamp/time zone),
• the previous value,
• the new/current value.

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 who made the changes. The audit trail is viewable and accessible to all users, but no user may create, modify, or delete an electronic record and its associated audit trial.
The audit trail can be opened by clicking on the symbol () on the right-hand side of the input field or at the bottom-left of a form.