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Site Activation Tools
Site Activation Requirements
PO Responsibilities
Miscellaneous
FINAL JEOPARDY!!!
100
This document includes steps that the PO should take to conduct the Site Activation Process and may be used by the PO to track progress.
What are the Work Instructions?
100
This module of CRMS is used by the sites to enter HSP/GCP certifications as well as population characteristics.
What is the Site Hub?
100
This is a visit requested by the PO after a site has been approved for development and expansion in order to assess overall capacity to conduct clinical trials.
What is a Site Assessment Visit?
100
This document is created by a CRS to describe their QA/QC process.
What is the CQMP?
200
This document includes steps that the sites must complete and links to relevant instructions and training websites, and should be used by sites to indicate progress.
What is the Site Activation Checklist?
200
These required trainings are for any staff member working with study participants or participant data and must be current within 3 years.
What is HSP/GCP?
200
This is a system of the State Department used to track foreign grant awards.
What is the Foreign Award and Component Tracking System (FACTS)?
200
Verification of lab requirements is protocol specific and covered by this process (which is also the official confirmation that a CRS may begin conducting a clinical trial/protocol).
What is Network Protocol Activation?
300
These two documents are sent to sites after they've been approved for development but before the Site Activation Checklist, in order to obtain details on key personnel and CRS characteristics.
What are the Essential Contacts and Site Profile documents?
300
This document must be created and maintained at the site to document completion of relevant training.
What is the Site Training Log?
300
This is the number of days that the OCSO PO has to respond to a CRS after receiving the Site Activation Checklist.
What is 15 days?
300
This document confirms that all necessary pharmacy equipment and pharmacy SOPs are in place for a site to conduct DAIDS-sponsored clinical trials.
What is a Pharmacy Establishment Plan (PEP)?
400
This document can be used by the PO to draft and send the final notification of Site Activation.
What is the Site Activation Notification Email Template?
400
These documents describe the site processes for Reporting Adverse Events, Essential Documentation, and Specimen Transport (to name a few).
What are required Site SOPs?
400
This is the minimum number of weeks in advance that a SAV or SIV should be requested.
What is 6 weeks?
400
This is a CRS or additional location that has not conducted NIAID HIV/AIDS clinical trials research with the last grant cycle.
What is a "new" CRS?
500
This online platform provides all DAIDS training courses, materials and resources for CRS staff.
What is the DAIDS Learning Portal (DLP)?
500
These documents describe DAIDS requirements in conducting clinical trials research and must be reviewed by all CRS staff (depending on role) and attested to.
What are DAIDS clinical research policies?
500
This is assigned to the site by NIAID CRMS after receiving a request from PO.
What is a CRS number?
500
This individual coordinates with representatives from the CTU/CRS, DAIDS Program, PAB, Network LOCs and others to confirm all items for DAIDS Site Activation have been completed.
Who is the OCSO PO?
500
These are the parties which must be notified of site activation in an email from the PO in a CRS affiliated with a CTU. (must name 5 of the group/individuals for full credit)
Who are OCSO, DCLOT, PAB, Program, OPCRO PR Team, CRMS, PPD (Monitoring Contractor), GMS, CTU PI, CRS Leader, CRS Coordinator, Network contacts.