Select your role, and then complete all the training sections.
At the bottom of each section, you will confirm you have read and understand each section by clicking on the blue button that looks like this:
You need to click this button to record that you read each page. when you do, a check mark will appear next to the side menu that has been completed.
At the end of the training, you will be required to pass a quiz that indicates you understand the training.
After successfully completing the quiz, you will be able to download a certificate of training for your files.
Once you have completed your training, a Pentara Data Manager will send you an invitation from Medrio to create a User Profile. The email will look like this:
Fill out the user profile.
Once you fill out the User Profile, you will be able to login to Medrio.
Data Entry - General Guidelines
Please watch this video first.
GENERAL DATA ENTRY GUIDELINES
These are general guidelines which apply to all the forms in the eCRF casebook:
Data must be entered within 3 to 5 days from the subject’s visit or as soon as source documents are available.
All eCRF casebook data fields must be completed.
All text fields should be entered in English and spelled correctly.
The use of abbreviations and acronyms should be avoided whenever possible. Only use abbreviations that are clear, unambiguous, and standard for medical use.
Ensure that Information entered into "Other, Specify" fields does not fit into a more appropriate category.
All dates must reflect the date of the assessments, NOT the date of form completion.
Do not enter extraneous data into a data field unless it helps to clarify the data point AND the extraneous data is not captured elsewhere on the eCRF casebook.
Do not use ditto marks, arrows or "same as above" notations in data fields. Note: These are not data and hence meaningless for analysis.
In some forms, data is entered into a table where one or more rows are necessary to accommodate the data. Examples of these are Adverse Events, and Concomitant Medications. If you need more rows, you can click one of the links at the bottom of the table to add more rows Don’t worry if you add too many blank rows. Only rows with data filled in are saved.
Any field that is marked with a red asterisk is a required field on the form and must be filled in before you will be able to save the form.
Note that some fields/values are parent fields and depending on your selections, will automatically hide fields/values that are not relevant. For example, selecting "Male" for the Sex variable will hide the "Childbearing Potential" field.
Entering Dates
Record dates using the following format: 2-digit month/ 2-digit month/ 4-digit year (Ex: 02/12/2020). Immediately below the date you will see the date in DD-MMM-YYYY format so you can check your work to make sure you have not transposed the day and months.
A complete date is expected for trial assessments and so these do not allow for unknown (UN) or partial dates.
Partial dates are allowed for historical dates such as in Medical History, and Concomitant Medications. As much Information as possible should be provided. If the Day is unknown but Month and Year are known, the date should be recoded (Ex: 12/UN/2020). At a minimum, a Year must be provided with Month and Day as UN (Ex: UN/UN/1998).
You can also use the date-picker icon that is immediately to the right of every date field.
When you click this icon, a calendar will appear, and you can use that to select the date you want.
Entering Times:
All times must be entered using a 24-hour clock format – see conversion chart below for assistance. For times around midnight, please use 23:59 of the current day or 00:00 of the following day. 00:00 signifies the beginning of the following day. UNK can be entered for unknown in some cases, but times are expected for trial assessments requiring a time.
12-hour clock
24-hour clock
12-hour clock
24-hour clock
12:00am
00:00
12:00pm
12:00
01:00am
01:00
01:00pm
13:00
02:00am
02:00
02:00pm
14:00
03:00am
03:00
03:00pm
15:00
04:00am
04:00
04:00pm
16:00
05:00am
05:00
05:00pm
17:00
06:00am
06:00
06:00pm
18:00
07:00am
07:00
07:00pm
19:00
08:00am
08:00
08:00pm
20:00
09:00am
09:00
09:00pm
21:00
10:00am
10:00
10:00pm
22:00
11:00am
11:00
11:00pm
23:00
Do not enter extraneous data into a data field unless it helps to clarify the data point AND the extraneous data is not captured elsewhere on the eCRF casebook.
Do not use ditto marks, arrows or “same as above” notations in data fields. Note: These are not data and hence meaningless for analysis.
In some forms, data is entered into a table where one or more rows are necessary to accommodate the data. Examples of these are Adverse Events, and Concomitant Medications.
If you need more rows, you can click one of the links at the bottom of the table to add more rows Don’t worry if you add too many blank rows. Only rows with data filled in are saved.
Optical Mark Reading (OMR)
OMR assessments will be completed on paper and submitted to the portal at
https://cloud.pentara.com
The OMR Assessments are:
ADCS-ADL
C-SSRS Baseline Screening
C-SSRS Since Last Visit
CDR-SB
COWAT
GDS
Hearing Test
MMSE
NPI-Q
ZBI
Once received, the OMR will send that data to the EDC.
When completing a document that utilizes OMR, please do the following:
1. Add subject specific and visit specific sticker to each page of the assessment (there is no need to additionally hand write this information on the forms).
a. These stickers are pre-printed for each subject and visit and are included in the MMSE packet shipments.
2. Complete the assessment, using a blue or black felt tip pen to complete the bubbles, if possible. It is not necessary to use a felt tip pen, however, it does significantly speed up the bubbling of items.
3. Enter if the subject’s assessment was completed, date of assessment, time performed (in 24-hour time), rater initials, and informant initials (as applicable) into the EDC (these items will not be entered using the OMR).
4. Scan and upload the assessments to the portal in the appropriate subject folder.
The file name should be SUBJECT ID_VISIT NUMBER_SCAN NUMBER. Scan numbers should be used in sequential order (scan 1, scan 2, scan 3, etc.). Example: 113-001-01-Scan1.pdf
All assessments can be scanned in one bulk file or separated out into multiple packets as needed.
5. If a correction is required, the correction should be made in the source and the corrected form uploaded to the portal using the next sequential scan number. Corrections should be made using a single line through errors and must be initialed and dated.
The OMR stickers will be included with the initial batch of MMSE Assessments.
For resupply, please send an email request to [email protected]
Login Screen
The Username is your email address. Your password will have been distributed to each study coordinator prior to SIV.
After logging in, on the left side menu select "Shared with groups."
Your Site should be listed there. Click on that site.
In the center of the screen you will now also see the same site. Click on that link.
This is the main portal screen for your site.
Here you will need to make a folder for each subject.
To make a new folder for a subject, click the "New" button at the top of the screen and select "New Folder"
Name the folder with the Subject ID. You can then enter that subject’s folder by clicking on the subject ID link.'
You can navigate back using the directory trail at the top of the page
When inside a subject's folder, you can upload scanned OMR forms by either dragging and dropping them on the subject's folder, or by clicking the Upload button, and selecting "Upload Files"
Adverse Events
Record Adverse Events as Medical Conditions, NOT Procedures, Therapies, Outcomes.
Tooth extraction (record reason for procedure, e.g., Impacted Wisdom Tooth) enter the Tooth extraction procedure on the Concomitant Procedure CRF.
Eye events, e.g., Redness (of Eyeball? of Eyelid?)
Ensure Information is Specific and Unambiguous.
Patient felt fuzzy (unclear if Unable to concentrate, Disoriented, Lightheaded, or other)
Eye Problem (unclear if Eye pain, Vision decreased, Retinopathy, or other)
Mouth sore (unclear if Mouth soreness or Sore (i.e., lesion) in the mouth)
Leg Infection (unclear if Skin, Joint, Bone, or Muscle infection of the leg)
Increased Urination (unclear if Increased Urinary Output or Increased Urinary Frequency)
Previous / Concomitant Medications
When working with subjects, ask them to bring their medications and supplements with them to the appointment. This way you can be precise with the identification of the product, its dose unit and form.
Prefer entry of the Trade name medication if possible. If not generic is ok.
Ranitidine (e.g., prefer entry as Zantac if trade name is known)
When entering supplements there are two ways to do it.
Enter the trade name of the supplement. This is by far the easiest way to identify a supplement. e.g., “CENTRUM SILVER MEN 50+”
Enter the ingredients of the supplement. You may need to resort to this if a trade name is not available or it is a generic. You may need to look at the label of the product.
In this case, you would enter Vitamin C, Citrus Bioflavonoid complex, and Rose Hips. The dose would be 1, and the dose unit would be Caplet. You do not need to enter each ingredient on its own line.
Record only one Trade Name medication or supplement per line.
Tylenol/Excedrin (record each as a separate entry)
Record multiple Generics together Only when they are a known combination.
Penicillin + Ibuprofen (enter each as a separate entry, since they are not manufactured together)
Hydrocodone w/Acetaminophen (okay, since they are manufactured together)
Ensure medication name is Accurate and Complete.
Vicks Sinus Nose Mist (Incorrect: e.g., enter Vicks Sinex Nasal Spray)
Tylenol Cold (Incomplete: e.g., enter Tylenol Cold Multi-Symptom Daytime)
Ensure medication is Specific and Unambiguous.
Advair or Flovent for Asthma (which one?)
IV Fluids (unclear if Saline, D5NS, Lactated Ringers, or other)
Analgesic (unclear if Aspirin, Hydrocodone, Meloxicam, or other)
Packed Red Blood Platelets (unclear if Packed red blood cells or Platelet concentrate)
When recording a drug's indication, select either Adverse Event, Medical History, or Prophylaxis
If you selected either Adverse Event, or Medical History, make sure that you have entered the associated AE or Medical History item(s) first so that you can reference the sequence numbers. The Sequence Numbers are the numbers to the left of the term boxes shown by the red arrows.
Enter up to 5 indication sequence numbers. For example if a subject is taking Tylenol for both a Headache (sequence 1) and Arm Pain (sequence 3), you would put a "1" in sequence box 1 and a "3" in sequence box 2.
When entering the drug indication for Prophylaxis, record the Drug Indication as a Medical Condition, NOT a drug class or type.
Antibiotic (Record the actual condition that this medication was used for: Pneumonia? Urinary Tract Infection? Tonsillitis?)
Anti-Coagulation (Record the actual condition that this medication was used for: Blood clot? Embolism? Thrombosis prevention?)
Supplement (for General health? Cardiac health? Pain prophylaxis?)
Surgery (for Sedation? Infection prophylaxis? Pain? Pain prophylaxis?)
Signing Forms
There are two ways of signing forms.
1) Individually (form by form)
2) In bulk (by subject or visit)
To sign forms individually:
Ensure the forms have been Completed, Reviewed by Pentara Data Management, and Monitored:
Click on the form you wish to sign on the page link on the left.
In the form, click the "PI approve" button in the upper right-hand corner. You can only sign a form if there are no outstanding queries.
When you click the button, you will be asked to electronically sign the form.
After signing, the form will indicate it has been signed in the Subject Progress.
To sign forms in bulk:
From the Manage Menu Item, select Bulk Approval. You will be presented with a tree view of subjects, visits, and forms that can be signed.
Here you have complete freedom to filter to sign what you want to sign. Click the "Apply"
Select any or all of the eligible forms to be signed. Note the forms with the red arrow cannot be selected because they have previously been signed.
Then sign the forms with your username and password and click the Approve button.
Unblinding Subjects
Unblinding a subject should only be done when you genuinely believe the health and safety of the subject depends on knowing which treatment group the subject is in. In this rare case, the Investigator can unblind an individual subject.
To unblind a subject
From the Manage Menu, select "Unblinding Subjects Report". You will be presented with an Unblinding Subjects Report parameters view.
Select "Subject" from the Unblind list. NEVER SELECT EITHER SITE OR GROUP ONLY SELECT SUBJECT. YOU RISK UNBLINDING YOUR ENTIRE SITE AND INVALIDATING THE RESULTS FROM YOUR SITE.
Enter the Subject ID of the subject you intend to unblind
Enter the reason for unblinding and click the "Update" button.
This will show you the treatment group of the subject.
Page Monitoring
On the Home Page, select from the list of subjects which subject you would like to monitor.
Select the page you would like to monitor.
You can now select the data points you would like to monitor. You can select each point individually, or you can use the select all button.
When you have the data points you want to approve, click the Approve button.
If you selected all of the data points, you will see this confirmation window.
If you selected a subset of the data points, you will see this confirmation window.
If you intended to only approve the data points you selected choose Approve Partial.
If you intended to approve all of the data points, you can select Approve Form, and it will Approve all of the data points even though you had not selected them all.
There may be a time when you need to unapprove a form. You can go to the form you need to unapprove.
When the entire form has been approved, you will have the option to unapprove the entire form.
When you click the Unapprove button you will see
When the form is partially approved, you will not see the Unapprove button. You will see the Approve button. It functions the same as the Unapprove button. It records any changes to the monitoring.
Managing Queries
When you come across something you need to query, you can do that at the point of data entry.
Each data point has an icon that you can use to query that data point.
Click the Query Icon, and you can enter some information about the query:
Query Designation - Select whether the query constitutes a protocol deviation or not
Query Description - Enter why you are questioning the data point.
Assign To - Select who should answer the query. You will want to select Study Coordinator, but you can select another role, or a specific user.
When you have entered the query information, click the Add button.
The data point will now have a icon next to it, showing an open query.
To manage this query, you can click on the icon.
Here you can Edit the description, close the query, Respond to the query, or change the assignment for the query.
Monitor Reports
Medrio has a variety of reports that may help you in your monitoring activities.
All Reports can be accessed from the Manage Menu.
Browsing Subject Data
There are two ways to review subject data:
1) Selecting the subject whose data you want to view under the home tab
2) Using the manage tab to review reports for all subjects
To review individual subject data:
Read Only access to subject data is available by selecting the subject whose data you want to browse.
Select the visit and CRF page name to view the form:
To review all subject data:
Select the Manage tab
Select Browse Data
Select the visit/form/item you want to review
Site Matrix
The Site Matrix is available from the Enter Data Menu. It is designed to give Clinical Operations a quick view of the status of each subject and the data entry status of each visit.
Study Management Options
The Study Management Options are available from the Manage Menu.
Query Listing
The Query Listing lets you list all queries in the system with a variety of filter options.
Study Documents
This EDC option is not being used for this study.
Download Forms
This EDC option is not being used for this study. All paper forms will be provided separately.
Clinical Operations Reports
The Reports are available from the Manage Menu.
BYO (Build Your Own) Reports
Standard
Data Audit Log - Full Audit Trail for the study.
Linked Data Report - Not Used For this Trial
Missing Data - Lists all forms with missing data that is expected. Drill-down is available to each form.
Missing Forms - List of all forms that are missing and are expected, and how late they are.
Study Data Summary - Site listing with enrollment, forms completed with %, and Queries with %
Build Your Own
The BYO report facility allows the user to build their own reports based upon three base reports
Form Status Report
Subject Data Trend Report
Clinical Data Report
After selecting a base report, add variables, with the options on the left side.
When you have the report structure you want, click the Run button.
Scheduled Visit Report
The Scheduled Visit Report gives you scheduled visits as of a specified date.
Query Aging Report
The Query Aging Report gives open and closing rates by site.
Top Queries Report
The Top Queries Report gives the source data of the most queries allowing focused instruction of sites for improvement.
Study Setup Reports
Data Dictionary - This report provides a complete data dictionary including all forms, variables, automatic queries.
Annotated Forms - This report provides raw-database annotated CRF forms
Randomization
As the unblinded statistician you are required to upload the randomization file and turn on randomization.
When you login, you will need to go to the Manage Menu, and select "Manage Randomization"
It is important that when uploading the randomization that the "Is randomization active?" be set to No.
icon that you can use to query that data point.
icon next to it, showing an open query.
