Welcome to PPD s guide to obtaining Oracle Clinical Remote Data Capture 4.6.x access. This guide has been written to walk you through the steps you will need to take in order to obtain OC RDC access for a clinical trial. In order to gain access to this clinical trial, you must complete the following: 1. Perform Oracle Clinical Remote Data Capture system training 2. Complete and submit an online Training Completion Form 3. Complete and submit an online RDC Account Request Form For all of the below steps, you will need to either click on one of the links below or enter the URL into your browser s Address bar: http://rdc.ppdi.com/server1 (OCDB5P) http://rdc.ppdi.com/server2 (OCDB3P) http://rdc.ppdi.com/server3 (OCDB2P) http://rdc.ppdi.com/server4 (OCDB1P) http://rdc.ppdi.com/server5 (OCDB4P) 1. TRAINING NOTE: If you have already performed PPD s OC RDC 4.6.2 training and need to only request access to your specific study, click Submit Account Request Form under the Getting Started section and go to section 3. Step Detail 1. Access training Use the Getting Started menu at the top of the page and select Online Training or use the Complete Online Training link located in the Getting Started for First Time Visitors section. OC RDC v4.6.x Training & Access Instructions PPD Proprietary Page 1 of 10
2. Browser resolution and Flash version test Before the training will open, a browser test has to be performed. As instructed on the page, click Here to test Browser resolution settings. If the browser resolution test is successful, the following will appear: Click Here to perform the Flash version test. If this test is successful, the following will appear: NOTE: If any issues are presented from the Browser resolution and/or Flash version test, contact the Support Centre (see below). OC RDC v4.6.x Training & Access Instructions PPD Proprietary Page 2 of 10
3. Commence training Select the appropriate option for the training you need to complete: Site User for Investigator, Sub I, Study Coordinator or other investigative site staff CRA for external CRAs, Data Managers and PVG personnel (also for CTM if providing backup to a CRA/Monitor) Read Only for PMs, CTMs, Sponsors or Auditors The training will open in a separate window and the first section Introduction to OC RDC xxx Training will provide all information you need to navigate through the training course. If you are not sure which option is appropriate for your role on the study, please contact your CRA / Monitor or the study Project Manager. 2. REGISTER TRAINING COMPLETION 1. Complete training When ALL lessons have been completed, you will be navigated to the Register Training Completion screen. Click the Next button to register your training completion. 2. Register training completion The Training Completion of OC RDC xxx Training (4.6.2) window will open. Enter all details in fields marked with *. Select your preferred option for receiving your copy of the form/training record. A copy of your training record is required for audit purposes file the form in your study binder. Click Submit. OC RDC v4.6.x Training & Access Instructions PPD Proprietary Page 3 of 10
3. REQUESTING STUDY ACCESS Now training has been completed and registered, you may proceed to requesting access to the required study. 1. Open Account Request Form When you click on Submit in the previous step, the following will appear: Click on the Account Request Form button to proceed with requesting access. NOTE: All fields on the access request form marked with * are required fields. OC RDC v4.6.x Training & Access Instructions PPD Proprietary Page 4 of 10
2. Form Section Protocol Access Requested The first section of the form relates to the Sponsor and study name(s) for which you are requesting access. Your CRA, Monitor or the study Project Manager should have provided you with this information. Please enter the details exactly as they have been written to avoid issues with invalid protocol names. 3. Form Section Contact Information Complete all of your information in the required fields in the Contact Information section. For the Country and Day of Birth fields, a drop down list is available use this to select the appropriate response. NOTE: Day of Birth is the day of the month on which you were born please select accurately, as any differences to previous or future responses will result in a second account being created for you. OC RDC v4.6.x Training & Access Instructions PPD Proprietary Page 5 of 10
4. Form Section Role Select the applicable option for the role you will be performing on the study. 5. Form Section Role = Investigator / Site Staff If you are an Investigator / Site Staff, when you select this role the form will change to ask for Site Information. Enter all required information. Select your role from the drop down list against the protocol. NOTE: If you are a sub investigator who serves as a back up to the Investigator / Principal Investigator and you need the ability to sign off / approve case report forms, you must select Investigator as your role. It must be agreed with the Sponsor that a Sub I can have approval privileges OC RDC v4.6.x Training & Access Instructions PPD Proprietary Page 6 of 10
6. Form section Initial Password Please enter an initial password to be set on your account when it is created. This password must be known only to you and you must remember this password. A notification of your initial password will not be sent when your account is created and access is granted. NOTE: If you already have an account for PPD s OCRDC system on this server, your password will not change and the password you enter on the form will be disregarded. 7. Form section Challenge Questions In order for the Support Centre to assist you with any login issues you may experience in future, you will need to verify your identity. The support centre will use the answers you provide here for that verification. You must remember these answers, otherwise you may not be able to obtain the support you need. NOTE: Please ensure the answers you provide are consistent with answers you may have previously provided. Failure to do so may result in a second account being created for you. 8. Form section User Agreement You must agree to the statements presented to be able to submit your request for access. OC RDC v4.6.x Training & Access Instructions PPD Proprietary Page 7 of 10
9. Form section Training Confirmation You must confirm that you have completed training in order to submit your request for access. If you select No or I do not know, a yellow box will appear advising you that training must be completed. The training will automatically open in a new window. 10. Form section Submission Please read the information in the submission section carefully before clicking Submit. You must also choose an option for a copy of the account request form to be delivered to you (Please note the Fax option may be removed in future). Click Submit. OC RDC v4.6.x Training & Access Instructions PPD Proprietary Page 8 of 10
WHAT HAPPENS NEXT? Your access request form is submitted to PPD for our Access Management team to review and ensure all required information has been entered, including the validity of Sponsor and study / protocol name(s). If all information is correct, the request is then sent on to the PPD study team for approval. NOTE: If the protocol name on the access request form cannot be identified as a valid protocol, or if the request is determined to be a duplicate of one previously received, the access request will be rejected and you will receive an email notifying you as such. If this occurs, it is recommended you speak with your PPD study contact. Once approved, the Access Management team will finalise the request and move it on for your account to be created and / or access to be granted. If access is successfully granted, you will receive an email notification containing valuable information relating to your completed request, including your userid and a link to your study s portal page. Remember, you will not receive a notification containing your password your password will be either your existing password or the one you entered on the access request form. CONTACTING THE SUPPORT CENTRE On all RDC Web Portals, there are links to the information you need to contact the support centre. PPD provides international toll free numbers for our customers to contact the support centre by phone. When you click on the option to Call the Support Centre or when you choose Support Centre Numbers from the Support Centre menu, the following screen will appear: OC RDC v4.6.x Training & Access Instructions PPD Proprietary Page 9 of 10
Click on the relevant area of the map for your region and a page similar to this will open: On this page note the code for your WorldPhone Access Number as you will be prompted to enter this when you call your Toll Free WorldPhone Access Number. Use the WorldPhone Directory to obtain the toll free number for your country all countries are listed alphabetically so you can simply click on the letter for your country and jump straight to that section of the directory. OC RDC v4.6.x Training & Access Instructions PPD Proprietary Page 10 of 10