Top IMPORTANT: You must "activate" your EDC account with NCIC CTG for the study you are involved in. If later you are involved in more than 1 study you will need to submit an SAAF form for access to those studies.

How to obtain a specific study account if you do not already have an active account in the EDC system:

1. Go to the specific trial's website. If you are already a participant on NCIC CTG trials and have a username and password to access the NCIC CTG web pages you should be able to access the trial specific webs site.
2. Under the Electronic Case Report Forms & Data Management Guidebook section click on the EDC Study Account Activation Form (SAAF) link. This will bring up the SAAF form for that specific trial. Print the form.
3. Complete ALL sections of the SAAF including a 4-digit PIN number of your choice (this number can be any combination of 4 digits except "1234") Note: - this is a very important number which you will need to remember. Please save it in a secure place.
4. Fax the completed SAAF to the fax number shown at the bottom of the form.
5. Once processed, The System Administrator will send you an email message providing you with:

• your Login Name
• your Activation Code
• a web link

How to obtain a specific study account if you already have an active account in the EDC system:

1. Go to the specific trial's website. Under the Electronic Case Report Forms & Data Management Guidebook section click on the EDC Study Account Activation Form (SAAF) link. This will bring up the SAAF form for that specific trial. Print the form.
2. Complete the "User Personal Information" section of the SAAF. Check "YES" for "Do you already have an ACTIVE account in the NCIC CTG EDC system?" Do NOT provide a new PIN. Enter your EDC User Name in the user name field and sign and date the form.
3. Fax the completed SAAF to the fax number shown at the bottom of the form.
4. You will be notified by the System Administrator when your study account is activated.
5. Use the same Login Name and Password as you have used before to log into the EDC system. Once into the system, all different studies for which you have been granted access will be displayed for you. Choose the appropriate study by clicking its name will bring you to your Site Main Page for the study in question.

Top The PIN number is the 4 digit code you created and placed on the Electronic Data Capture (EDC) Study Account Activation Form (SAAF). It is your own personal number. This form was probably completed by you when requesting an EDC account for a specific trial. It would have then been faxed to NCIC CTG for processing as an EDC account cannot be created without a PIN number. A copy should have been kept with you or with whomever requests the EDC accounts from your site.

This is a very important number and it should be guarded the same way as a secure password.

It is important that you keep this number as it is required in activating your account. It is also need in situations where;

• you have forgotten your password and need to generate a new one;
• your account is locked out and needs to be unlocked

If after attempting to locate your PIN you still cannot find it, please contact NCIC CTG through their helpdesk system. Or email your request to support@ctg.queensu.ca

Top The Activation code is a code that you will use to activate your Electronic Data Capture (EDC) account. The Activation Code is sent to you after you have faxed your EDC Study Account Activation Form (SAAF) to NCIC CTG. The System Administrator will have processed your form and will have sent an email to you with;

• your login user name;
• the activation code that is used to activate your account in EDC;
• the weblink to the EDC system.

Top If you have filled out your SAAF form, here are the steps to activate your account.

When the SAAF was submitted with your PIN you should have received back an email with your username and an Activation Code and a web link to the EDC system.

1. Click the web link in the mail. This will take you to the activation screen and automatically enter the activation code into the proper field. If you use the link please skip to step 3 below. If you do not use the link or it does not work you can also type in the URL address for EDC into your web browsers address bar. The address is https://edc.ctg.queensu.ca.
2. On the EDC login page, click the Activate New Account link.
3. On the Account Activation Request screen enter the Activation Code (if it is not automatically entered for you) from the email you received. Then enter your PIN number in the required field.NOTE: if you are using the key pad of your keyboard please ensure the Num Lock is on so that you are entering numbers correctly.
4. Click Activate Account
5. You should then be taken to the New Password screen.
6. Create your password in the "New password" and "Confirm password" spaces provided. The password must be a minimum of 6 digits long and must contain both letters and numbers. It is case sensitive.
7. Click "Save password and continue". Your password is now valid in the system. It will remain active for 180 days.

From this point forward you will only use the username sent to you and the password you created to access EDC.

After activating the account and creating the password, you will then need to complete the web based e-training for EDC. The link to this training should appear once you have logged in.

What if I cannot activate my account? If you cannot activate your account, please look for any error messages that may appear. If the activation does not work and the activation gets locked out, a new activation code will need to be sent to you. If this happens please contact the NCIC CTG Helpdesk. Please provide details on the issue and any errors or messages you received while trying to activate the account. You can reach the heldesk by clicking here. You can also email them at support.ctg.queensu.ca.

Top There have been issues where the E-Training has seemed to freeze or hang at certain pages. People have described it as the page seems to get stuck loading. Example: Page 5 is completed. They click next. It shows loading the next page but it never seems to complete or it stops at a certain percentage.

Some possible solutions to try;

1. Ensure your pop up blocker is turned off. The training uses other windows that a pop-up blocker might stop from loading.
2. Let the page load entirely before trying to skip to another section/page. The page will often need to fully load before it activates other links/buttons
3. To skip ahead if the page gets stuck, you want to click on the "Menu" tab in the bottom left corner of the training session window. This will bring up the names of all the pages for the training session. Click on the next page (example - page 6 hangs, click on page 7) If that doesn't work try clicking on the page before the one that got stuck, after that page is done loading skip ahead to the page after the one that gets stuck. (example - page 6 hangs, click on page 5) Once the page fully loads go to the menu and click page 6, If you are still stuck, try clicking page 7. As a last resort try going back a series of pages and then rapidly clicking next to get to the page you need to get to.
4. If the problem persists, please try this at another computer. The issue is often local to the PC. By going to another system you remove the possible issues with the first computer. Also, it could be the local network and the system's ability to pull information across the network.

One of the above solutions usually fixes the problem, and allows you to carry on with the training session. If the issue persists, please contact the NCIC CTG helpdesk by clicking here. You can also email them at support@ctg.queensu.ca.

Top If you forget your password you can access the system as follows:

1. Access the Login Page bytyping the URL address for EDC into your web browsers address bar. The address is https://edc.ctg.queensu.ca..
2. Click on "Forgot Password?". This will take you to the "Lost Account Information Screen".
3. Enter your First Name, Last Name and PIN number and click the "Recover Account" Button. This will take you to the New Password Screen.
4. Enter your password twice in the "New password" and "Confirm password" spaces provided. Please ensure to follow the Password Guidelines: it must be a minimum 6 characters long and must contain numbers and letters.
5. Click "Save password and continue".
6. Click "click here to continue" and you will be granted access into the system.

Note: If you forgot both your password and PIN contact the NCIC CTG Systems Administrator through the NCIC CTG helpdesk by clicking here. Or by email at support@ctg.queensu.ca.

Top Note: This is for situations where you have already activated your EDC account and have been using your password. If your password is entered incorrectly 4 times in a row, your account will get locked out. If it that happens you should see a message that the account is locked out.

You can try to unlock the account yourself. To do this you will need the following information;

• Your name;
• Your PIN number

You can then follow these steps;

1. From the EDC login page, click Forgot Password
2. On the Recover Account page enter your first name, last name and the PIN number
3. Click Recover Account
4. You will then be asked to create a new password
5. Once done you will have unlocked the account, created a new password and have been logged into the EDC system. You will now use this newly created password to log into EDC from this point forward until it expires, you change your password or your account gets locked out again.

If you are unable to unlock your account, please contact the NCIC CTG helpdesk by clicking here. Or by email at support@ctg.queensu.ca. Please make sure to include details of the issue, any messages or errors that you have received.

Top System-generated queries in EDC may be closed automatically once the data is fixed. However, manual queries in EDC (i.e., those manually created by an SC) may stay open until the response has been SC reviewed and then subsequently closed.

Top There is a known issue with slow or non-functional drop down menus in EDC if you are using Internet Explorer version 6 or earlier. (Other browsers & versions may also be affected) As a first course of action, have your IT Team upgrade your Internet Browser.

Top In order to obtain a copy of your EDC training certificate.
Log into EDC at https://edc.ctg.queensu.ca/MedidataRAVE/
In the upper right corner click on My Profile.
On the right hand side under My Profile click on the eLearning link.
Under the Certificate Heading you will see a paper icon.
Click on that icon and a pop up will occur allowing you to save or open your certificate in PDF format.
You can then print this certificate for your records.

Top In order to re-take the EDC Training.
Log into EDC at https://edc.ctg.queensu.ca/MedidataRAVE/
In the upper right corner click on My Profile.
On the right hand side under My Profile click on the eLearning link.
Under the Start Heading you will see a play button icon.
Click on that icon to re-take the EDC training.

Top You can locate your Website User ID by accessing our Account Management Tool here.Once on this page please click on Find My Website User ID. You can then enter one of two options your Email Address or your Centre Code and Trial Code. Your Website User Id will then be mailed to you.

Top You can reset your Member Password by accessing our Password Management Tool here.Once on this page please click on Password Reset. You can then enter your Website User ID and your Email Address. Your new temporary password will be e-mailed to you.

Top Mango Help documentation is located here.