Pra Training - Novartis Program - 04 Jun 2020

1. Who updates Impact My Sites with the actual SIV date once it is completed?

SSL

CSM

CRAM

CRA

The CRA updates IMPACT with the actual SIV date once is completed.

Explanation

The CRA updates IMPACT with the actual SIV date once is completed.

2. As a CRA, are you responsible to ensure the site has received the Investigator's brochure?

True

False

As a CRA (Clinical Research Associate), it is indeed the responsibility to ensure that the site has received the Investigator's brochure. The Investigator's brochure contains important information about the investigational product, including its composition, pharmacological properties, and potential risks and benefits. It is crucial for the site to have this document as it helps the investigators and site staff to make informed decisions and conduct the study safely and ethically. Therefore, the statement "True" is correct.

Explanation

As a CRA (Clinical Research Associate), it is indeed the responsibility to ensure that the site has received the Investigator's brochure. The Investigator's brochure contains important information about the investigational product, including its composition, pharmacological properties, and potential risks and benefits. It is crucial for the site to have this document as it helps the investigators and site staff to make informed decisions and conduct the study safely and ethically. Therefore, the statement "True" is correct.

3. Provides relevant information related to the site, any trackers, system access during the handover process is an obligation of the:

CRAM

Transferring CRA

Receiving CRA

CSM

During the handover process, it is the responsibility of the Transferring CRA to provide relevant information related to the site, any trackers, and system access. This means that the Transferring CRA is obligated to share all necessary information and resources with the Receiving CRA, ensuring a smooth transition and continuity of operations.

Explanation

During the handover process, it is the responsibility of the Transferring CRA to provide relevant information related to the site, any trackers, and system access. This means that the Transferring CRA is obligated to share all necessary information and resources with the Receiving CRA, ensuring a smooth transition and continuity of operations.

4. How do you document any training before a SIV?

Remote monitoring report

Site Initiation Visit report

Contact report

Monitoring report

Contact report.

Explanation

Contact report.

5. Who is responsible to ensure the site has received a protocol amendment?

CRA

CTA

SSL

CSM

The SSL tracks in a spreadsheet. For central IRB approvals, the SSL will manage them.

Explanation

The SSL tracks in a spreadsheet. For central IRB approvals, the SSL will manage them.

6. Who is responsible to file the PI change form in Subway or CREDI?

CSM

SSL

CRAM

CRA

The correct answer is CRA. In Subway or CREDI, the person responsible for filing the PI change form is the CRA.

Explanation

The correct answer is CRA. In Subway or CREDI, the person responsible for filing the PI change form is the CRA.

7. Rollover or extension studies that were screened and participated in the pre-requisite trial require a SSV?

True

False

Rollover or extension studies that were screened and participated in the pre-requisite trial do not require a site selection visit (SSV). This means that these studies do not need to go through the process of selecting a site for conducting the study. The participants and screening process have already been established in the pre-requisite trial, so there is no need for an additional SSV. Therefore, the answer is False.

Explanation

Rollover or extension studies that were screened and participated in the pre-requisite trial do not require a site selection visit (SSV). This means that these studies do not need to go through the process of selecting a site for conducting the study. The participants and screening process have already been established in the pre-requisite trial, so there is no need for an additional SSV. Therefore, the answer is False.

8. Who can acknowledge a safety notification in a site?

PI

Regulatory coordinator

Sub-I

All above

All of the above options (PI, Regulatory coordinator, and Sub-I) can acknowledge a safety notification in a site. This means that any of these individuals have the authority and responsibility to acknowledge and respond to safety notifications in a site.

Explanation

All of the above options (PI, Regulatory coordinator, and Sub-I) can acknowledge a safety notification in a site. This means that any of these individuals have the authority and responsibility to acknowledge and respond to safety notifications in a site.

9. When you are transferring a site to an another CRA, a remote report or on-site visit report is required.

True

False

When transferring a site to another CRA (Clinical Research Associate), it is necessary to provide a remote report or an on-site visit report. These reports help ensure that the transfer process is properly documented and that all necessary information is communicated between the parties involved. This allows for a smooth transition and ensures that the site is being properly managed and monitored by the new CRA. Therefore, the statement "True" is correct.

Explanation

When transferring a site to another CRA (Clinical Research Associate), it is necessary to provide a remote report or an on-site visit report. These reports help ensure that the transfer process is properly documented and that all necessary information is communicated between the parties involved. This allows for a smooth transition and ensures that the site is being properly managed and monitored by the new CRA. Therefore, the statement "True" is correct.

10. The safety notifications can be only acknowledged in One Connect

True

False

The safety notifications can be downloaded or printed.

Explanation

The safety notifications can be downloaded or printed.

11. Who is responsible to track the IRB approval date in a trial?

CRA

CTA

CSM

SSL

SSL, which stands for Site Study Lead, is responsible for tracking the IRB (Institutional Review Board) approval date in a trial. The Site Study Lead is typically a member of the research team who oversees the study at a specific site or clinical research center. They play a crucial role in ensuring that all necessary approvals and documentation are in place before the trial can proceed. Tracking the IRB approval date is important to ensure that the study is conducted ethically and in compliance with regulations.

Explanation

SSL, which stands for Site Study Lead, is responsible for tracking the IRB (Institutional Review Board) approval date in a trial. The Site Study Lead is typically a member of the research team who oversees the study at a specific site or clinical research center. They play a crucial role in ensuring that all necessary approvals and documentation are in place before the trial can proceed. Tracking the IRB approval date is important to ensure that the study is conducted ethically and in compliance with regulations.

12. After the RIS is signed, is the CRA responsible to send notification of a FDA 1572 change to DRA?

True

False

True. The CRA send the notification of FDA 1572 changing to Drug Regulatory Affairs.

Explanation

True. The CRA send the notification of FDA 1572 changing to Drug Regulatory Affairs.

13. All documents related to a 1572 change need to be filed in CREDI/Subway prior to sending the notification to DRA?

True

False

In addition, DRA (Drug Regulatory Affairs) ensure everything is good to go to ship drug to the site.

Explanation

In addition, DRA (Drug Regulatory Affairs) ensure everything is good to go to ship drug to the site.

14. Carol Smith is a new data coordinator of your site. You need to request a OCRDC account for her. Which kind of form do you choose in SNOW?

SSUARF Clinical Users - requires manager approval

SSUARF Site Users - requires manager approval

SSUARF Site Users - does not require manager approval

SSUARF Trial Data Manager

The correct answer is "SSUARF Site Users - does not require manager approval." This form should be chosen in SNOW to request an OCRDC account for Carol Smith because it does not require manager approval. This means that the data coordinator can directly request the account without needing approval from their manager.

Explanation

The correct answer is "SSUARF Site Users - does not require manager approval." This form should be chosen in SNOW to request an OCRDC account for Carol Smith because it does not require manager approval. This means that the data coordinator can directly request the account without needing approval from their manager.

15. Who is responsible to send protocol amendments or IBs to the sites?

SSL

CSM

CRA

CTA

CSMs are responsible to send via one Connect, Secured e-mail or One-drive

Explanation

CSMs are responsible to send via one Connect, Secured e-mail or One-drive

16. Regarding the Field Monitor Responsibility log, all the sentences are correct, with the EXCEPTION of:

It is a mandatory form

Completed from Site Selection Visit to Close-out Visit

To be updated when CRA responsibilities changes

Start date of incoming CRA should match the end date of outgoing CRA

It is completed from SIV to COV

Explanation

It is completed from SIV to COV

17. Who is responsible to assign a receiving CRA to the trial site in CTMS system?

Transferring CRA

CRAM

SSL

CSM

The Clinical Site Manager (CSM) is responsible for assigning a receiving Clinical Research Associate (CRA) to the trial site in the CTMS system. The CSM is in charge of managing the overall operations and coordination of clinical trials at the site, including assigning CRAs to specific trials. They ensure that the CRAs are properly trained and equipped to carry out their responsibilities effectively.

Explanation

The Clinical Site Manager (CSM) is responsible for assigning a receiving Clinical Research Associate (CRA) to the trial site in the CTMS system. The CSM is in charge of managing the overall operations and coordination of clinical trials at the site, including assigning CRAs to specific trials. They ensure that the CRAs are properly trained and equipped to carry out their responsibilities effectively.

18. Who orders regulatory binders for a site?

SSL

CTA

CSM

CRA

The regulatory binders are requested by CRA

Explanation

The regulatory binders are requested by CRA

19. When there is a PI change, the CRA is responsible to complete a PI change form. Where is this form found?

Web Consumer

One connect

US TMO SharePoint library

Site Cockpit

US TMO SharePoint library as this is a local process.

Explanation

US TMO SharePoint library as this is a local process.

20. The CRA is always responsible to update site personnel in IMPACT.

True

False

The CSM also updates in Progress.

Explanation

The CSM also updates in Progress.

21. Who is responsible to create the s-TOC?

CRA

CSM

SSL

CTA

SSL is responsible to create the S-TOC and the CRA is responsible to update it.

Explanation

SSL is responsible to create the S-TOC and the CRA is responsible to update it.

22. Investigator's brochure needs to be sent to PI during the start-up phase.

True

False

Per ICH GCP E6(R2) §5.6.2, before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator Brochure, and should provide sufficient time for the investigator/institution to review the protocol and the information provided.

Explanation

Per ICH GCP E6(R2) §5.6.2, before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator Brochure, and should provide sufficient time for the investigator/institution to review the protocol and the information provided.