ATAFUTI InForm Database Training Presented by: Southampton Clinical Trials Unit

ATAFUTI InForm Database TrainingPresented by: Southampton Clinical Trials Unit

Following this presentation you will be able to:• Log in to, and navigate around, the InForm

database

• Screen and enroll patients

• Enter, amend and review patient data

• Add comments to the system

• Answer data related queries

• Explain the PI sign off process

Using InForm to enter data

ContentsContentsLogging in to InForm for the first time

Navigation around InForm (1-3)

Screening and Enrolling a Patient – an overview

Adding a patient to the screening log (1-7)

Enrolling a patient (1-6)

Enrolling patients with “exceptions” (1-3)

Patients not joining the study (1-6)

Adding trial data to Inform – an overview

Locating a patient’s records (1-4)

Entering patient data:

Initial Visit (1-8), 3 Month Notes Review (1-5), Subject Diary, Adverse Events (1-6), Concomitant Medication (1-6), Pregnancy Notification (1-5), End of Study, Subject Contact Details (1-5)

Advanced InForm functions – an overview

Advanced InForm functions :

Amending data (1-2), Audit trail, Eraser function, Adding comments (1-7), Answering data queries (1-4), Principal Investigator Signature (1-3)

InForm works via your web browser and supports Internet Explorer 6.0/7.0/8.0 on Microsoft Windows OR Safari 3.2.1 on Apple Mac.

Please note that the screenshots used during this presentation have been taken from a training environment and therefore may differ slightly to the finalised system in functionality/appearance.

The appropriate hyperlink and log-in details will be provided as part of your site’s initiation.

Logging in to InForm for the first time

Navigate around InForm via the series of icons at the top of the screen.

Navigation around InForm (1)

Icon DescriptionEnroll Contains Eligibility and Screening Log data

Subjects Data repository for all patient data collected through the study

Queries View all (current and historic) queries raised

Signatures Used by P.I. to electronically “sign” when a subject’s data is complete

Documents Additional documentation to aid your use of InForm (not currently in use)

Admin Technical information including InForm version number

Action buttons appear in the lower right corner of the screen.


Icon Description

Submit Save data entered on screen

Return Returns you to previous page WITHOUT saving data

Add Candidate Add a potential subject for the trial

Enroll Confirm a patient’s eligibility and consent

Do Not Enroll Used for patients that have been screened but do not join trial

Shortcut icons appear at the top right of the screen.


Icon DescriptionSearch facility Locate an individual subject

History Lists recently viewed CRFs

Home Shows navigation icons

Help Contains InForm specific guidance

Exit Log out of InForm system

Your profile Reset password

All patients screened for the study are recorded on InForm even if not they do not subsequently join the trial.

Over the next few pages we will review the process of entering data on to the electronic screening log. There are several instances where a patient may be removed from the enrollment procedure; we will highlight the process for creating an eligible, consented patient here.

Patients that become ineligible as a result of failing eligibility criteria OR who decide not to join the study will be covered in further detail at the end of this section.

Screening and Enrolling a Patient – an overview

Access the electronic screening log by clicking on the Enroll icon. The form contains the following information and should be completed as you screen the patient:

Adding a patient to the screening log (1)

Item Description

Screening date Date patient was screened

Subject Initials (3 letters) Capital letters, middle initial or use “-”, e.g. M-B

Inclusion Criteria Must all be ticked Yes to join study

Exclusion Criteria Must all be ticked No to join study

Eligibility Reason for entry/non-entry to trial

To add a new subject to the screening log click on the ‘Add Candidate’ action button located in the bottom right of the screen.



To add the Screening Date either:

• Individually select the drop down boxes for day/month/year:

• Use the calendar button alongside the date:

Enter the Subject Initials using CAPITAL letters.

TOP TIP! Note that if the patient has no middle initial please use a hyphen to split the initials.


Complete the Inclusion Criteria by clicking on the appropriate radio buttons.


Repeat the process with the Exclusion Criteria.


To complete the process scroll to the bottom of the screen and confirm the patient’s eligibility and willingness to partake in the study.

Remember to the information using the action button.


If the patient is eligible and consents to the trial the second stage of the “Enrollment” process will occur. In this section we will cover:

Enrolling a patient (1)

Item DescriptionDate of informed consent Date patient was consented to study

Pregnancy test Outcome of test or reason not performed

Is subject still eligible Yes or No dependent on pregnancy test result

Subject trial ID 3 digit Site ID + 3 digit Subject Pack Number

Current symptoms Baseline record of symptoms and patient’s temperature

Once the patient has signed the Informed Consent Form locate the subject you have screened. Click on the Enroll hyperlink to confirm the patient’s eligibility.


Enter the date informed consent was given by the subject. Confirm the patient is not pregnant (a positive test result will be covered later in this guide) and confirm the patient is still eligible.


As the patient has been confirmed as eligible their specific trial ID will now be confirmed. Enter this in to the Subject Trial ID Number section.

Complete the patient’s current symptoms using the drop down list.


List of symptoms Classification

Fever, Pain in side, Blood in urine, Smelly urine, Burning, Urgency, Daytime frequency, Tummy pain, Restricted activities, Unwell

To complete the enrollment enter the amount of days the subject has had symptoms and their current temperature.

Click .

The system will ask for final confirmation that you wish to enroll the patient.

Confirm by clicking the button in the bottom right of the screen.


Congratulations – you have successfully enrolled a new patient on to InForm!

TOP TIP! Note that the system will flag the 3 month review date which you can schedule into your diary.

To begin entering trial data use the action button.


A patient with a pain in the side rated as >=moderately bad and/or symptoms that have lasted over 14 days can join the study where agreed (as per protocol).

In these instances the system will ask for confirmation that this is acceptable upon clicking the option.

Enrolling patients with “exceptions” (1)

Enter the requested information:

TOP TIP! Note that we will check all patient’s eligibility criteria to ensure that they meet the standard required to enter the study.


Item Description

Date / Time When the decision was made

Approved by Name of responsible practitioner

Title Role on study

Reason Full details of why the criteria has not been fulfilled

Click to continue.

TOP TIP! If the enrollment confirmation screen has highlighted that a patient should not be joining the study the function can be used.

In the event of an typographical error use the button to go back and amend the data.


If the patient is ineligible, or decides not to join the study for another reason, their details should still be recorded on the electronic screening log.

As before, go via the tab and click on . Enter the following:

Patients not joining the study (1)

Item Required?

Screening date YES

Subject initials YES

Inclusion/Exclusion criteria YES, unless subject has declined study

If the patient decides not to join the study then complete the first section of Q19.


If the patient fails the screening criteria complete the inclusion/exclusion criteria and the second section of Q19.

Click to enter the data. No more data entry is required for this patient.


There may be instances where the patient appears eligible but provides a positive pregnancy test. Complete the first page of enrollment as per normal.

Click to continue to the second stage of the enrollment process.


Item Comments

Screening date

Subject initials

Inclusion/Exclusion criteria Tick “pregnant” question as NO at this stage

Eligibility Answer YES to “Did the subject enter the trial”

Locate the patient and click on the Enroll hyperlink.

Complete the “Date ICF was signed by subject” (Q1). Record the positive result of the pregnancy test and mark the subject as now being ineligible (Q2 and 3).


DO NOT enter a subject ID or the current symptoms (Q4-17). Click .

TOP TIP! Note that the electronic screening log will display a red cross next to the patient. This is a visual indicator that the patient did not join the study.


All trial data is held within the Subjects tab on InForm. Over the next few pages we will review the process of entering data on to the visits undertaken for ATAFUTI:

• Initial Visit

• 3 Month Notes Review

• Adverse Events/Concomitant Medications

• Pregnancy Notification

• End of Study

• Subject contact details

Adding trial data to InForm – an overview

InForm uses a “traffic light” colour scheme to provide a visual indicator of a subject’s progress through the trial.

Locating a patient’s records (1)

Icon/colour Description

Green All data entered in this section with no issues

Yellow Incomplete section - some data entered

Grey Section not started

Question mark Section contains one or more queries to answer

To access or input a patient’s data click on the Subjects icon.

This will provide a display of each of your patient’s current progress through the trial broken down by visit.


Click on the appropriate visit you wish to review, e.g.

• To access subject 999999’s ‘3 Month Notes Review’ click the box highlighted below.


The corresponding visit will appear on your screen and you can begin to enter/amend your patient’s data as required.


Each visit is broken down into several subsections known as ‘forms’. The ‘Initial Visit’ CRF contains the following forms.

Entering Patient Data - Initial Visit (1)

Form Description/ContentsDOV Date of Visit –initial visit date

EL Eligibility – confirmation of eligibility

SC Subject Characteristics – patient demographics

Bas Pro Baseline Procedures – samples and symptoms

Res Anti Rescue Antibiotics – duration and doses

LB Report No access – Southampton CTU use only

To add the Date of Visit either:

• Individually select the drop down boxes for day/month/year:

• Use the calendar button alongside the date:


To save the data entered click the button. Once the Date of Visit has been submitted the corresponding visit item will change to green. This form has now been completed.


The Eligibility form, seen here as ‘EL’, populates itself from the Enrollment (Screening) tab so does not need to be re-entered.

TOP TIP! Note how a full description of the EL abbreviation appears when you hover your cursor over it. This applies to all forms in InForm.


SC, or Subject Characteristics, pre-populates with some key items from the Enrollment tab (trial ID, subject initials and ICF date).

TOP TIP! NHS number is no longer being collected and is hidden from view. As this cannot now be entered the icon will remain yellow even when the month/year of birth has been submitted. Continue to the next form (Baseline Procedures) once birth details have been entered.

Enter the Month/Year of birth and click on the button.


Bas Pro, or Baseline Procedures, also carries over information from the screening process, namely the patient’s current symptoms and temperature.

Confirm the MSU sample has been collected and the contact details recorded by clicking on the Yes buttons and pressing .

If either process has not occurred you must provide a reason in the text box provided. The Contact database will be reviewed at the end of the session.


Record any rescue antibiotics on the Res Anti form. Enter the duration in days alongside the appropriate drug and click .

NB: The most common antibiotics have been listed for ease of use.


Antibiotics Action requiredTrimethoprim 200mg bd Enter duration – in days

Nitrofurantoin 100mg qds Enter duration – in days

Nitrofurantoin 100mg MR bd Enter duration – in days

Nitrofurantoin 50mg qds Enter duration – in days

Other, please specify Enter full details – drug, duration and dose

Once all the sections have been completed every form within the visit will have changed to green (except the LB report section which will be subsequently completed by the Southampton CTU).

This confirms that you have entered all the required data for the Initial Visit.


The ‘3 Month Notes Review’ CRF contains the following subsections.

Entering Patient Data – 3 Month Notes Review (1)Form Description/Contents

DOV Date of Visit –3 month review date

Medical Notes Review

Details of any UTI consultations since date of screening

AECMSAE Reminder to check for AE, CM and SAEs

Enter and submit the DOV (Date Of Visit) using the date the notes are being reviewed, e.g. this should be 3 months after the patient’s registration.

Then move to the “Med Notes Rev” form which stands for Medical Notes Review.

TOP TIP! Note that the DOV is automatically added as the “Date of Medical Notes review”. The calculated 3 month review date will also appear to help confirm the timescale for you to report on.

Entering Patient Data – 3 Month Notes Review (2)

If the patient has had any further consultations for UTI(s) since the date of screening you can add an additional entry for each visit.

These are created via the “Add Entry” button (located on the right of the screen).


Enter the date of consultation and whether any antibiotics were prescribed (include dose, frequency and duration).

Click to save the data.


Repeat the process for any additional visits.

TOP TIP! Note that you can review or amend the individual visits by clicking on the individual hyperlinks next to each entry.


The AECMSAE form is a reminder to log any Adverse Events, Concomitant Medications or SAEs as required by the protocol. Remember that if the answer is yes then the details must be recorded on the AE CM visit (covered further in this training).

TOP TIP! Note that the first question relates to SAEs and is read only. SAEs must be reported through the normal paper format and this question will show as incomplete (yellow) until updated by our Quality Team.


The diary form will be updated by the Southampton CTU. However, this will be available to sites in read-only format.

The transcription will appear under the ‘SD or Recall” visit.

Entering Patient Data – Subject Diary (1)

Adverse events should be recorded via the AE CM visit. To create an AE tick Yes on the ‘Any AE/CM’ form.

TOP TIP! If the patient has not experienced any AEs (confirmed as part of the retrospective three month notes review) remember to ensure the No button is ticked.

Remember to !

Entering Patient Data – Adverse Events (1)

An additional form, ‘AE’, will appear on the left hand pane. Click on this to display the AE form.


Multiple events can be added as required. To create an AE click on the New button displayed on the top of the screen.


The Adverse Event form contains the following information. Complete all the appropriate fields and .


ItemAE Number (view only) Start Date Description of Adverse Event

CTCAE term (split into 3 alphabetical sections)

Event reported as serious (if yes then ensure an SAE is reported to Southampton CTU)

SAE number (view only)

Item reconciled (view only)

Event related to trial agent CTCAE/Severity

Outcome (if not yet resolved this may be left incomplete until the reporting period is complete)

Repeat the process for all AEs.

TOP TIP! Note that as you add each AE it is added to the summary dropdown list found at the top right of the screen. This can be used to navigate through the AEs.


If an AE needs updating, e.g. it is now resolved, the view will default to a visual breakdown of each entry.

Click on the icon next to the AE you wish to amend. any amendments.


Concomitant medication should be recorded via the AE CM visit. To create a CM entry tick Yes on the ‘Any AE/CM’ form.

TOP TIP! If the patient has not required any CMs (confirmed as part of the retrospective three month notes review) remember to ensure the No button is ticked.

Remember to !

Entering Patient Data – Concomitant Meds (1)

An additional form, ‘CM’, will appear on the left hand pane. Click on this to display the CM form.


Multiple events can be added as required. To create an CM click on the New button displayed on the top of the screen.


Concomitant Medication is added in the same way as Adverse Events. Complete the appropriate fields.

TOP TIP! If a CM is related to an AE please always enter the AE first.


ItemCM Number (view only) Start Date Generic Name of Medicine

Dose Unit of Dose Route of Administration

Frequency of Administration

Indication (should match AE description)

Due to an AE (enter corresponding AE number here)

Ongoing (if not yet resolved this may be left incomplete until the reporting period is complete)

Note that when entering CMs the screen automatically displays all AEs on the split screen underneath. If a CM is related to an AE then the appropriate AE(s) should be ticked before clicking .


If a CM needs updating, e.g. no longer being taken, the view will default to a visual breakdown of each entry.

Click on the icon next to the CM you wish to amend. any amendments.


If the patient has fallen pregnant during the reporting timescale a ‘Pregnancy Notification’ form should be completed. These are created via the New button (located at the top right of the screen).

Entering Patient Data – Pregnancy Notification (1)

Enter the following details:

Entering Patient Data – Pregnancy Notification (2)Question DescriptionDate of Report Date first made aware of pregnancy, e.g. subject advises is

pregnant

Reported by Name of medical professional first made aware of pregnancy

Date of Pregnancy Confirmed Date pregnancy was confirmed by test

Consent for Pregnancy Monitoring Obtained

Use date Informed consent Form was signed

Estimated date of delivery

The predicted delivery date

Pregnancy Outcome Elective abortion/uneventful OR other outcomes (report as SAE)

Remember to once you have completed the form.

TOP TIP! Note that the form will remain “yellow”, e.g. incomplete, until Pregnancy Outcome is completed.

The screen will display an overview of the information entered.


When the pregnancy outcome is known this field can be updated. To access the Pregnancy Report click on the square yellow icon.


Enter the outcome and as per normal. It is imperative that if the outcome is anything other than an elective abortion/uneventful birth this must be reported as an SAE through the usual reporting channels.

TOP TIP! Note that the form will change to “green” once completed.


When the subject has finished their study involvement the End of Study visit should be completed. Enter as per the table below before clicking .

Entering Patient Data – End of Study (1)

Question DescriptionDate of Completion / Discontinuation

Date of the 3 month note review unless the patient left the trial prior to this date. If patient has passed away this should be the date of death.

Did they complete the study

Answer yes unless:

Subject was lost to follow up

Subject withdrew

Patient passed away

Patient was withdrawn due to clinical or eligibility reasons

The ATAFUTI Contact database is accessed via a separate hyperlink which will be supplied to you separately.

TOP TIP! Repeat the Logging On procedure previously covered in this manual. Note that your password may differ between the two systems.

Only eligible patients that are successfully enlisted to the trial should have their details recorded here. To begin click on the Enroll tab and add a candidate.

Entering Patient Data – Subject Contact details (1)

Enter the Subject Initials and .

TOP TIP! The patient’s initials and trial ID must match that held in the main database.


Locate and click upon the Enroll hyperlink.


Enter the trial ID and click .

Confirm that you want to add the patient by pressing the button.

Select to begin entering their contact data.


Enter the required information and click .

Log out of the contact database.

Entering Patient Data – Subject Contact details (5)DescriptionRandomisation date, First name, Surname, Main telephone number, Alternative telephone number, Email address, Contact notes

There may be instances where you are required to amend or comment upon the data held in the database. In this section we will cover the following aspects.

Advanced InForm functions – an overview

DescriptionAmending existing data

Audit trail

Eraser function

Adding comments

Data queries

PI signatures

You can alter erroneous data held within the database. Hover over the data that requires amendment and click.

TOP TIP! The data field will turn blue when it can be amended.

Amending data (1)

The data field can now be amended. A reason for the change is also required before clicking on .

Amending data (2)

If an item is amended the audit trail icon will change to yellow.

Click on the icon to view the history.

To close the audit history page press the button.

Audit trail (1)

Data can be cleared from a field wherever you see the eraser button.

Click on the icon to clear any data previously entered.

Eraser function (1)

Free text comments can be added to either an individual item or a whole form.

To add comments to a form use the Add Comment icon located in the upper right of the screen.

Adding comments (1)

Enter the comment in the box and .

Adding comments (2)

A dialog box will appear to confirm your comment has been saved. Click to confirm and then to the form. Note the Comment icon background has changed to yellow.

Adding comments (3)

Comments can also be added alongside individual items on a from.

To add use the Add Comment icon located to the right of the item.

Adding comments (4)

Items can be set as “Not Done” via the comments facility (if appropriate). Click on the comment icon.

TOP TIP! This function will not appear if the answer contains data.

Adding comments (5)

Click the appropriate radio button and ensure you provide a free text reason why this field cannot be completed. and .

Adding comments (6)

Note that the question item will automatically reflect the comment, e.g. the usual answers available have been replaced by “Not done”.

Adding comments (7)

There are rules built in to the database which will flag if an item appear erroneous or does not meet the trial criteria. For this example we will use a date in the future, e.g. 1st December 2015.

Note the query which appears directly underneath the item. To review this item click directly on the query text or the red query icon.

Answering data queries (1)

Two options for responding to the query will appear. You can either update the data, e.g. a transcription error had occurred or provide a free text response as to why the item is correct.

For this example we will use the button. Click on this to access the item. By amending the value to 1st June 2015, and entering a reason for change, the query disappears once has been clicked.

TOP TIP! Note the tick that appears alongside the query icon confirming the successful closure of the query.


If the item field is believed to be correct then the function should be used. This does not amend the data.

Provide a response in the free text box provided.

Remember to your answer.


The response will be reviewed by the Southampton CTU. If further information is required then the query can be reopened. This will subsequently appear on InForm as a new query to be reviewed.

TOP TIP! A breakdown of all queries at your site can be viewed via the Queries tab.


When all the data is completed (e.g. fully entered, no outstanding queries and the End of Study form is completed) the PI can electronically sign the patient records.

TOP TIP! This functionality is only accessible by the PI at site.

Click on the Signatures tab to access a list of patients at site.

Principal Investigator Signature (1)

Locate the patient ID and click the Sign Book hyperlink (located alongside the subject).


The PI should read the affidavit carefully before re-entering their user name and password.

TOP TIP! Note that if any patient data is subsequently amended the patient’s CRFs will become automatically “unsigned” and the process would then need to be repeated.


If there are any queries please do not hesitate to contact us:

[email protected]

02381 203 983

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