[Liberian Observer] A six-member ECOWAS delegation visiting Liberia yesterday concluded a consultative meeting with the leadership of the Liberian Senate, with the Speaker assuring Senators that the delegation was here to seek clarity, and facilitate mediation.

[Economy] :
A large delegation representing Czech power authorities will make a two-week visit to South Korea for working-level negotiations ahead of the conclusion of a final contract for the Czech nuclear power plant project.  Korea Hydro and Nuclear Power(KHNP), which was selected in July as the preferred bidder ...

[more...]

Washington, D.C. -- NAB Show the world’s largest annual conference for broadcast , entertainment and technology professionals, will host attendees from 154 countries and exhibiting companies from 38 nations at the 2022 NAB Show, held April 23 – 27 in Las Vegas, Nev.

BELGRADE, 22 May 2016 – The European Union Delegation to Serbia and The OSCE Mission to Serbia have taken note of the wide-ranging personnel changes at Radio Television Vojvodina (RTV) undertaken by the newly appointed managing board.

We should like to take this opportunity to recall the weighty responsibility of RTV as a public broadcaster to ensure that it meets the highest standards in safeguarding the public interest, guaranteeing the quality and diversity of its programme content and ensuring the impartiality of its editorial policy, following the principle of independence enshrined in the 2014 Law on the Public Media Services.

RTV has an additional, important responsibility to discharge in meeting the legitimate expectations of national minorities with regard to access to broadcasting in minority languages.

Moreover, we recall the importance of creating an enabling environment in Serbia in which freedom of expression can be exercised without hindrance, strengthening the independence of the Regulatory Body for the Electronic Media in order better to support editorial independence, and ensuring adequate funding to public broadcasting as well as its editorial independence.

For more information & media inquiries please contact:

Aleksandar Djordjević , EU Delegation to Serbia, Media and Information Officer,

e-mail: aleksandar.djordjevic@eeas.europa.eu, Phone: +381 11 30 83 200.

Ivana Milatović, OSCE National Political and Press Affairs Officer,

e-mail: ppiu-serbia@osce.org, Phone +381 11 3606 151

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Nazir SiyalKARACHI: Jeroen Willems, Head of Cooperation at the European Union Mission to Pakistan, called upon Speaker of the Provincial Assembly of Sindh, Syed Awais Qadir Shah, here on Tuesday. CEU Mission to Pakistan leader Jeroen was accompanied by Ms. … read more

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National Bureau of Economic Research

The 18-member expert delegation included food scientists, medical doctors, IT specialists, agriculture specialists, global health researchers, finance and energy specialists, policy administrators from India, Azerbaijan, USA, Canada, Nigeria, Bangladesh, Kenya, UK, Uganda and Austria

The biggest cause of such fires is non-delegation of tasks to responsible people with clearly defined accountability. When you delegate, you have to allow time for people to step up and demonstrate their abilities.

Auto Expo 2020: Chinese delegation to skip event due to coronavirus scare

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We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principal Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.

That’s what makes the Delegation of Authority (DoA) log so important and why regulatory inspectors care about it so much. A DoA log serves as evidence that a PI has assigned study tasks only to those staff members with the education, training, and experience to carry them out. If delegates are unqualified to perform their tasks, subject safety could be at risk and it’s highly likely that the study data would be unusable.



Monitors – you can really make a big contribution here. At the outset of the study, you can verify that your PI has made appropriate delegations and the DoA log is complete. You can cross-match the log with training records, CVs, licenses, and source documents and correct any problems as early in the study as possible. Then, throughout the study, you can verify that the DoA log is being maintained.

Coverage
Without referencing any other site document, monitors can spot two types of DoA log omissions.

(1) Missing Assignments. Are there study tasks to which no one has been delegated? The tasks in a DoA log are often represented by a short code to conserve space. A legend at the end of the log translates the code into its corresponding task. Monitors can compare the legend to the DoA log entries to see if any tasks are omitted.


(2) Gap in Assignments. Due to staff turnover, reassignment, leaves of absence, etc., delegation for a task frequently does not last the duration of the entire study. A column in the DoA log indicates the delegation start and stop date.  Monitors can check to make sure that when the delegation for a task ends for one staff member, it is picked up by another.

Qualifications
Once you’re satisfied the DoA log completely covers all tasks for the duration of the study, you can check to make sure delegates have the necessary qualifications. You’ll want to compare the log with training records, CVs, and medical licenses from the regulatory binder.

• Has the staffer charged with recording vital signs during a subject visit been formally trained to take blood pressure? Is it documented?
• Did an incoming pharmacist receive protocol training prior to the start date of his study assignments?
• Does state law allow a registered nurse to dispense investigational product, or is a nurse practitioner or physician’s assistant required? Does the protocol require only an M.D. conduct certain procedures? Does the DoA log show the requirement is being followed?

Study Procedures
Even after the focus of the monitoring visit moves past the DoA log itself, you should revisit the log during source document review.

• Have any study tasks been conducted by staff members who have not received official delegation to do so?
• Perhaps the protocol requires a blinded IP dispenser. If so, has the delegated dispenser conducted any other study procedure?

PI Oversight
The PI is responsible for ensuring subject safety, compliance with the regs and the protocol, and control of the investigational product. That obligation cannot be delegated away. PI oversight is critical to a successful study, and the DoA log is where PI oversight starts.

Procedures that are performed by unqualified or ineligible personnel put both study participants and study data at risk. These are the very things regulatory inspectors work to guard against. Good monitors know it and make verifying the DoA log a priority.

__________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

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