Please review for details the attached Standard Operating Procedure RCB SOP 901 Project Request and Approval , which defines the procedure used for requesting services for clinical research projects and documented here. PI/ Responsible Person name* must provide value
Degrees
Full title (to be addressed)* must provide value
Department:* must provide value
Email Address:* must provide value
Phone number:
Extension:
Street
City* must provide value
Alert Bay Black Creek Bowser Brentwood Bay Campbell River Cassidy Castlegar Cedar Chemainus Chetwynd Chilanko Fork Cobble Hill Colwood Comox Coombs Cortes Island Courtenay Cowichan Bay Crofton Cumberland Dawson Creek Deep Bay Denman Island Duncan Errington Fanny Bay Fort St. John Gabriola Island Galiano Hornby Island Koksilah Lady Minto Ladysmith Lake Cowichan Lantzville Lazo Malahat Mayne Island Merville Messachie Lake Mill Bay Moberly Lake Nanaimo Nanoose Bay North Saanich Parksville Pender Island Port Alberni Port Alice Port Hardy Port McNeill Powell River Quadra Island Qualicum Qualicum Beach Quathiaski Cove Queen Charlotte City Quesnel Royston Saanichton Salt Spring Island Shawnigan Lake Sidney Sointula Sooke St. Georges - Granada, West Indies Tahsis Thetis Island Tofino Victoria Vancouer Weyburn Woss Youbou Ucluelet Unknown Other
Please enter city
Is Contact person different from PI? Yes
No
Contact Person (if different than PI) name
Degrees
Full title (to be addressed)
Department:
Email Address:
Phone number:
Extension:
Project Title:* must provide value
Title to be displayed on project webpage
Project Acronym for quick reference:* must provide value
If same as title- just write 'same'. It should be less than 25 characters
Please describe briefly your project:
Purpose of this project:* must provide value
Practice / Just for fun
Operational Support/Health Services Management (HSM)
Research
Quality Improvement
Other
What Program Quality Council this request is reporting to? Adult ICU Brain Health Youth & Family Electronic Health Record Emergency Heart Health Lab Long Term Care Medical Imaging Medicine Mental Health & Substance Use Palliative
Please specify:
Are you planning to collect Personal information Yes
No
Ethics requirement: REB approval required
Non-REB approved (ie operational, administrative)
Does the project have the appropriate director level approval? Yes
No
Please contact ISAP for consultation. You can review the Privacy Impact Assessment Amendment Summary that pertains to your project here: Would you like to get a copy of the full PIA? Yes
No
Has already REB approval (has to be approved before entering data)? Yes
No
After completion of your study, do you need your data to be stored in REDCap for a period of time? Yes
No
After completion of your study, do you need your data to be removed from REDCap immediately or after a period of time? Yes
No
If you decide to use our services, we will register the date of completion for your study and define the date of removal for your data. It will be your responsibility to inform the REDCap Data Manager of the closure of the study with Research Ethics. REB/IRB Number:
Select all that apply: Basic or bench research
Clinical research study or trial
Translational research 1 (applying discoveries to the development of trials and studies in humans)
Translational research 2 (enhancing adoption of research findings and best practices into the community
Behavioral or psychosocial research study
Epidemiology
Repository (developing a data or specimen repository for future use by investigators)
Other
Proposed environment: REDCap Internet
REDCap VIHA Intranet
REDCap VIHA Intranet is meant to run identifiable projects and is ONLY accessible through VIHA network (No multi-centre studies nor external collaborators)
Use survey(s) in this project? Yes
No
After creating data collection instruments in the steps below, you and other users in this project may enter data for those instruments. Additionally, you may enable any instrument as a survey and then collect data for that instrument from survey respondents. The only difference is who will be entering the data: project users, survey participants, or both. For surveys, you may utilize a Participant List for emailing your recipients and also to track who has taken your survey(s). And if your first data collection is enabled as a survey, then you may use a public survey link, which is a single link that can be emailed to all participants or even posted on a website.
Time related project: Classic (each form available for use only once for each subject/record)
Longitudinal/ repeating forms (each form available for use one or more times for each subject/ record)
The 'classic' data collection format is the best option if all data collection instruments will only need to be used once for each subject/record in the project. If some instruments need to be utilized repeatedly to collect data numerous times (e.g. using an instrument named 'Visit Data' over ten visits for the same subject), the 'longidutinal / repeating forms' option will likely be best. Additionally, the longitudinal format also allows the use of the scheduling module, if needed.
Is this a Randomized project? Yes No
Ongoing study?
Yes No
Number of Subjects/ Participants subjects enrolled in the study or participants responding a survey. If ongoing project, please provide annual estimate
Number of Questions/ Variables each distinct piece of data (it can be asked several times, though) (Ex. height, diagnosis, have transplant (y/n), etc.)
Number of Forms/ Instruments homogenous group of questions applied at the same time(s). Ex. demographics, surgery, quality of life questionnaire
Number of Visits/ Events: Data collection time points where data is collected for each subject (ex Baseline, 6 Months follow up, etc.). If ongoing visits, please enter 99
Number of Sites/ Groups: different institutions/hospitals participating in data collection
Nature of Subjects: De-identified (no full name, full address, nor personal numbers like PHN or BCCH) Please upload any related document (protocol/scanned paper form/diagram/image) that may be helpful to understand the setting of your project.
Project Start Date Today D-M-Y
Project End Date Today D-M-Y
Duration of project (calculated) View equation
months
or time/units of duration
weeks months years
Require additional RCB Informatics/Statistics services: Yes No
Additional services include: creating project forms, creating randomization model, importing data form another database, preforming statistics on your project, etc.
Include a description of your additional request:
The RCB will contact you to discuss additional request(s) for your project. As each request is unique, details regarding the services required may affect the overall cost of your project, which will be outlined in the letter of collaboration. Details of the request will be summarized in the Project Definition Form.
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