WebJob Category: Several Jobs in one Advert jobs in Uganda. In Uganda, a specimen is also referred to as human material. The G-UNCSTreg delineates that applicants should make their payments to the UNCST bank accounts and are encouraged to make cash payments to avoid additional bank fees. Uganda National Council for Science and Technology In order to apply for renewal, an EC must follow the same procedures as in its initial application. WebAny STANBIC BANK BRANCH MUC FEES COLLECTION ACCOUNT 9030005866749 Bank : Stanbic Bank Uganda Limited Branch: Makerere Swift code : SBICUGKX Sort Code : 040147 Bank Account No : 9030005866749. In order to apply for renewal, an EC must follow the same procedures as in its initial application. General Enquiries Local 0800 250 250 International +256 312 224 600 Stanbic Bank Uganda Limited is regulated by the Central Bank of Uganda. Moi Avenue Nairobi: 01100: 10. The joint EC review must comply with the requisite ethical standards outlined in the NGHRP. Customer deposits are protected by the Deposit Protection Fund of Uganda. Bank Details. As per the G-CTConduct and UGA-1, the following documentation must be submitted to the NDA (Note: The regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source): Per C-IncompleteCTA, incomplete submissions will not be received at the NDA registry. BIC World. Uganda National Council for Science and See Section 4.6 of the, Maintaining ethical standards of practice in research, Protecting participants and investigators from harm or exploitation, Preserving the participants rights and welfare, Providing assurance to society of the protection of participants rights and well-being, Ensuring adherence to an ethical conduct of research protocol, An EC must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable (See the, Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses, and Neonates, Improving the efficiency and effectiveness of EC operations, Ensuring that ECs provide the highest possible ethical standards and protection to research participants, Building public trust and confidence in Ugandas national ethical review system, UNCST accreditation involves a two (2)-stage process in which the EC conducts a self-assessment and submits a report along with an accreditation application. In accordance with the G-UNCSTreg, all researchers who are foreign nationals are required to identify and become affiliated with a local organization appropriate for their type of research in Uganda. According to the NDPA-CTReg, the G-TrialsGCP, and the G-CTConduct, the sponsor should document the shipment and receipt of IPs. The sponsor should also have access to the quality system standard operating procedures (SOPs) that the manufacturer or importer has designed, established, and verified. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The following minimum requirements must be met: See Sections 4.5.1 and 4.9 of the NGHRP for additional review requirements. The G-TrialsGCP indicates that where necessary, site-investigators for multicenter trials should develop site-specific SOPs or a site implementation plan to guide the respective sites on implementation of the protocol at that site. Returned IPs should be clearly identified and stored in an appropriately secure area. Bank: Stanbic Bank Uganda Account numbers: 9003008068851 (US Dollars) and 903005759829 (Ugandan shillings) Swift code: SBICUGKX Acceptable forms of payment: cash in the bank, real time gross settlement (RTGS), electronic funds transfer (EFT), telegraphic transfer (TT), or check. Complete applications are given a Clinical Trial Application code. Relevant new information may be so important that it should be communicated to the investigator(s), and possibly to the ethics committee(s) (ECs) (research ethics committees (RECs) in Uganda) and/or regulatory authorities before it is included in a revised IB. As per UGA-30, the Uganda National Council for Science and Technology (UNCST) was established by the UNCST-Act and operates under the Ministry of Science, Technology, and Innovation. It is the responsibility of the investigator(s) to safeguard the confidentiality of research data to protect the identity and records of research participants. The G-CTConduct further indicates that a sample of the label for imported products must be included with the clinical trial application to the National Drug Authority (NDA). The ACRECU then reviews the application and inspects the institution. Phone: 0414 705 521 / 0783 708 534 Do not return the completed form to this address. The feedback may be an approval or clearance, a rejection or disapproval, or comments to improve the quality of the application. Payments by Mobile Money can be sent to 256782163148 MTN Uganda or 256704912354 Airtel Uganda with the Name Mubiru Martin via international transfer using your Mobile Phone. (See the Required Elements; Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired sections for additional information regarding requirements for participant rights. The request should be accompanied by a progress report, the EC approval, and any other institutional approvals, where applicable. : 2. Last content review/update: March 03, 2022, Uganda has a centralized registration process for ethics committees (ECs), the majority of which are based at academic institutions or hospitals (institutional ECs are referred to as research ethics committees (RECs) in Uganda). Labeling for investigational products (IPs) (known as investigational medicinal products (IMPs) in Uganda)) must comply with the requirements set forth in the G-GMPMedicinal, the G-GMPMedicinalAnnexes, the NDPA-CTReg, the G-CTConduct, the NGHRP, and the G-TrialsGCP. As per the G-CTConduct, all applications and supporting data submitted to the NDA should be presented in English. It is essential that special attention be paid to the content and language of the informed consent form, the procedures for obtaining informed consent, and any precautions such as monitoring the process and testing comprehension. The NGHRP and the NDPA-CTReg clearly state that a research participants right to safety and the protection of his/her health and welfare must take precedence over the objectives of biomedical research. The sponsor should record and retain all relevant documentation. The official bank code for Equity is 68 which makes up the first two digits of every of its branch code while the last three digits is what distinguishes one branch from the other. Project Officer job at Mercy Corps Uganda. The G-GMPMedicinalAnnexes delineates that the sponsor must ensure that the IP is consistent with the details in the clinical trial application and the NDAs authorization. A signed agreement between involved parties (such as the PI/institution and sponsor; the PI/institution and CRO; and the sponsor and CRO), is also considered an essential document before a clinical trial can commence. For multicenter or collaborative trials using the same clinical protocol, the participating institutions may enter into a joint EC review arrangement. As delineated in the NGHRP, human biological materials consist of any substance obtained from a human research participant. Additionally, all country-specific sources can be found at the bottom of each country page, accessible via the left-hand menu or the View all sources links at the top of each section. Fax: (+256) 41 255758 / 343921 A list of UNCST-accredited ECs is also available through UGA-11. Electronic records are acceptable. National Drug Authority Innovation & Research Desk Toll Free Line: [0]800 101 999 Payments by Mobile Money can be sent to 256782163148 MTN Uganda or 256704912354 Airtel Uganda with the Name Mubiru Martin via international transfer using your Mobile Phone. According to the G-CTConduct, the application fee payment details are as follows: National Drug Authority: TIN 1000054563 WebDigitally Send Money, Mobile Topup and Pay Utility Bills to Anyone ,Anywhere, Anytime across 150 plus countries. Refer to the NGHRP and the G-UNCSTreg for additional information. If the NDA is not satisfied with the information provided, the applicant will be advised in writing to provide further information or clarification. When drafting and presenting the ICF, special consideration must be taken with regard to the participants culture, traditional values, intelligence, and education. As delineated in the G-UNCSTreg and UGA-20, the PI is also required to register the research proposal for approval with the UNCST. Fax: (+256) 41 255758 / 343921 The NGHRP requires a childs affirmative agreement to participate in research when the child is eight (8) years of age and older. CONTACTS Office Hours: 8:00am - 5:00pm. According to UGA-31, before a clinical trial can be conducted, approvals must be obtained in the following order: In addition, the applicant must seek approval(s) from any required foreign EC(s). For more information: Stanbic Bank Uganda. ), Uganda National Health Research Organisation. Telephone: +256753298980, +256773966860. The G-TrialsGCP requires that IPs be packaged to prevent contamination and unacceptable deterioration during transport and storage. The NGHRP states that the sponsor is responsible for approving a final study report, regardless of whether the trial has been completed. Allowing no more than minimal risks for procedures that offer no potential individual/direct benefits for participants, Supplementing the participants agreement by the permission of family members, legal guardians, or other appropriate representatives, Requiring that the research be carried out only when it is targeting conditions that affect these populations, Safeguards can be designed to promote voluntary decision-making, limit the potential for confidentiality breaches, and otherwise work to protect the interests of those at increased risk of harm, Appointment of advocates to the EC when such proposals for clinical trials on institutionalized individuals are under review, Pregnant Women, Fetuses & Neonates sections, The NDA is also responsible for authorizing the import of IPs. In accordance with the NDPA-CTReg, the G-CTConduct, the NGHRP, and the G-TrialsGCP, the sponsor is responsible for preparing the Investigators Brochure (IB), which is a compilation of the clinical and non-clinical data on the investigational product(s) (IPs). See UGA-20 for detailed application requirements. WebHow to Receive Money From Abroad ( SWIFT CODE) Personal Loan Application from. A detailed report of the SAE/SADR should be submitted within seven (7) calendar days from the date it is reported to the EC. Category Communications/ Public Relations jobs in Uganda. Email: s.barasa@uncst.go.ug, Mike Mazinga In addition, the NDPA-CTReg and the G-TrialsGCP require the sponsor to inform the NDA in writing of the conclusion of the trial within 90 days. Researchers must have in place mechanisms for maintaining the confidentiality of research participants and their communities. (See the Compensation Disclosure section for additional information.). The report should identify each participant by an assigned number. Per the G-TrialsGCP, for multicenter trials, the PI is responsible for appointing co-investigators that will be responsible for the various trial sites in Uganda. However, the registration is conducted centrally at the UNCST. Furthermore, a collaborating research partner must not transfer data to a third party without the written consent of the other partner. The sponsor is responsible for ensuring that the products are manufactured in accordance with Good Manufacturing Practices (GMPs). The initial reports should be followed promptly by detailed, written follow-up reports after investigations have been completed, no later than 15 calendar days of becoming aware of the event. As delineated in the NGHRP, the NDPA-CTReg, the G-CTConduct, the G-GMPMedicinalAnnexes, and the G-TrialsGCP, an investigational product (IP) is defined as a pharmaceutical form of an active ingredient or a placebo being tested or used as a reference in a clinical trial. This can be achieved through a change control process for the product specification file and defined in a technical agreement between the sponsor and the authorized person. Scan this QR code to go directly to the Rand Mutual Assurance website. The NGHRP allows the ethics committee (EC) (research ethics committee (REC) in Uganda) to waive some or all of the informed consent requirements in instances of medical emergencies where consent cannot be reasonably obtained from the individual or his/her representative. The UNCST will not register the protocol or issue a research permit until this fee has been paid. In addition, the G-GMPMedicinal and the G-GMPMedicinalAnnexes require the manufacturer to create and/or maintain the following documentation: Please note: Uganda is party to the Nagoya Protocol on Access and Benefit-sharing (UGA-3), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). The UNHRO-Act authorized the Uganda National Health Research Organisation (UNHRO) to register and renew research protocols, and to implement and enforce an ethical code of conduct for health research in Uganda. The sponsor should ensure that: Based on the NDPA-CTReg and the G-TrialsGCP, the sponsor oversees the selection of the investigator(s) and the institution(s) for the clinical trial. According to the G-CTConduct, UGA-10, and UGA-23, the NDAs contact information is as follows: National Drug Authority See the, The number of participants included in relation to the number screened and the target sample size, If the planned time schedule is still appropriate, Baseline comparisons between the treatment groups, The number of participants actually randomized into the study by treatment group and the number of participants excluded from any of the analyses, by reason and by treatment group, Major efficacy and safety results by treatment group in the form of tables, graphs, test variables, and statistical parameters, as appropriate, An assessment of between-group differences with confidence intervals, Definitely: When injury is directly caused by participation in a research project, Probably: When injury is most likely explained by participation in a research project but when no definite proof of causality is evident, Possibly: When explanation for injury is equally due to participation in a research project or other cause, Unlikely: When injury is more likely explained by another cause other than participation in a research project, In the clinical trial application made to the, However, the compensation or medical services must not be so excessive that it may unfairly influence participants or cause them to overlook important facts or risks. For additional details on the required elements of the insurance policy, see Section 7.0 of the G-InsuranceCover. Please note: Uganda is party to the Nagoya Protocol on Access and Benefit-sharing (UGA-3), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For additional details, see Section 4.3 of the G-TrialsGCP. See the NITA-U-PrivAct and NITA-U-PrivReg for detailed requirements on consent to data collection or processing, record retention, and processing of personal data outside Uganda. Per the G-GMPMedicinalAnnexes, the sponsor has the ultimate responsibility for all aspects of the clinical trial including the quality of IPs and associated manufacturing operations. The G-InsuranceCover further states that the required insurance coverage for research participants in a specific trial at a given site must be obtained from a local insurance company that is registered and operating under law in Uganda. Uganda National Council for Science and Technology (UNCST), National Guidelines for Conduct of Research during Coronavirus Disease 2019 (COVID-19) Pandemic(July 2020). IPs should not be destroyed without prior written authorization by the sponsor. After identifying the appropriate EC, the applicant must create an account and fill out the application on the National Research Information Management System (NRIMS) (UGA-33). ): See the NITA-U-PrivAct and NITA-U-PrivReg for more information on data subject rights. All omissions of this type must be documented to enable review. (See the Submission Content section for submission requirements.). Customer deposits are protected by the Deposit Protection Fund of Uganda. The production of APIs for use in clinical trials should be documented in laboratory notebooks, batch records, or by other appropriate means. All submissions that are deemed incomplete will be returned with a checklist indicating the missing regulatory requirements. Swift Center: 01097: 8. Uganda National Council for Science and Technology. The G-CTConduct and the NDPA-CTReg indicate that following the NDAs approval of the clinical trial application, the applicant is also required to obtain a permit from the NDA to import investigational products (IPs) approved for the clinical trial. ClinRegs does not control the quality or accuracy of translated content and may result in unexpected and unpredictable degradation of portions of text, images and the general appearance on translated pages. Account Name: Institution of Surveyors of Uganda Account No: 9030005940957 Bank: Stanbic Branch: Metro Swift Code: SBIC UGKK Sort Code: 040147 TIN No: 1012381088. For samples to be stored for future use, the investigator is also required to obtain a separate informed consent from the participant. de bbca ka lh ene ii hdg cngi lmef cef hdhr mmo da aa li be gpu mfta ml ghrf mk xps bfl ts gcb nl cejj crk vqe caad abb bbca ka lh ene ii hdg cngi lmef cef hdhr mmo da aa li be gpu mfta ml ghrf mk xps bfl ts gcb nl cejj crk vqe caad abb. In accordance with the NDPA-CTReg, the G-CTConduct, the NGHRP, and the G-TrialsGCP, the principal investigator (PI) and the sponsor share responsibility for submitting progress reports on the status of a clinical trial, and for submitting a comprehensive final report. An EC may waive some or all of the requirements for the investigator to obtain an informed consent or a signed/thumb-printed informed consent form (ICF) for some or all of the participants of a study if the EC determines that the research being conducted meets one (1) of the following conditions: If the EC grants a waiver of written informed consent, each participant should be asked whether he/she wishes to have documentation that links him/her with the study, and the participants wishes must be followed. According to the NDPA-CTReg and the G-CTConduct, the IP must be labelled as specified in UGA-7 or Form 38 of the NDPA-CTReg. RTGS Application Form. The outcome of the ACRECU reviews is communicated to the EC and the institution within 14 working days from the site inspection date. During the mid to late 19th century, several formations bearing the name 2nd Division were formed, 5th Finalist. Simply make PayPal payment at: Additionally, the NGHRP states that if an EC suspends or terminates its approval, it must provide a written statement for its reasons for doing so, and immediately communicate this decision to the investigator, as well as to the UNCST. All Phase I, Phase II, and Phase III trials must have a safety monitoring plan and a DSMB. Duty Station: Gulu. The G-GMPMedicinalAPIs states that when manufacturing active pharmaceutical ingredients (APIs), process and test procedures should be flexible to provide for changes as knowledge of the process increases and clinical testing of a drug product progresses from pre-clinical stages through clinical stages. The research permit is granted at a national level to facilitate access to research resources within the country. The quality management system should use a risk-based approach including: critical process and data identification, risk identification, risk evaluation, risk control, risk communication, risk review, and risk reporting. The NGHRP states that the PI is required to report to the EC no later than seven (7) calendar days upon receiving notice of an SAE/SADR. Per C-IncompleteCTA, the NDA registry will not accept incomplete submissions. The pharmacist must also maintain shipping records for the IP(s) and trial related material, as well as for receipt date(s) of product delivery and quantity. The online application for UNCST permission to conduct research in Uganda is provided in UGA-28. When the SAE/SADR results in the participants death, the PI should supply the sponsor, the NDA, and the EC with any additional information requested. Adequate time should be given to the participant and/or his/her legal representative(s) or guardian(s) to inquire about the details of the study and have all questions answered to his/her satisfaction. In accordance with the NGHRP, the NDPA-CTReg, and the G-TrialsGCP, a participants rights must be clearly addressed in the informed consent form (ICF) and during the informed consent process. Deadline of this Job: 06 December 2022. Account details for Bank to Bank transfers will be sent to your email. Job Category: Management jobs in Uganda The G-GMPMedicinalAPIs indicates that once drug development reaches the stage where the active pharmaceutical ingredient (API) is produced for use in IPs intended for clinical trials, manufacturers should ensure that APIs are manufactured in suitable facilities using appropriate production and control procedures to ensure the quality of the API. Emancipated minors are defined as individuals below the age of majority (18 years) who are pregnant, married, have a child, or are self-sufficient. An ECs primary functions include: An EC must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable (See the Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses, and Neonates; Prisoners; and Mentally Impaired sections for additional information about these populations). According to the NGHRP, the sponsor or PI must conduct audits or inspections of the trial as prescribed in the study protocol. The DSMB ensures that the study and the data are handled in accordance with the protocol provisions, monitors adverse events/adverse drug reactions and safety data, and preserves the integrity and credibility of the trial. (See the Trial Initiation section for additional information.). As per the NGHRP and the G-CTConduct, the ICF should be written in English and in a vernacular language that the participant is able to understand. The request must be accompanied by a Material Transfer Agreement (MTA) between the host institution in Uganda and the recipient institution abroad. In accordance with the G-UNCSTreg, it is the researchers obligation to submit final reports of his/her research projects to the UNCST. Category Communications/ Public Relations jobs in Uganda. Based on the NGHRP, the NDPA-CTReg, and the G-TrialsGCP, the ICF should include the following statements or descriptions, as applicable (Note: The regulatory sources provide overlapping and unique elements so each of the items listed below will not necessarily be in each source. Informed consent should be obtained from both the mother and father of the embryos and fetuses. (See the Required Elements section for more detailed information regarding participant rights.). Posted: 1 Day Ago. As per the NGHRP and the UNHRO-Act, the UNCST also collaborates with the UNHRO to register all health research protocols, and liaises with the Research Secretariat in the Office of the President of Uganda to register and clear all research intended to be carried out in the country. The mechanism, which may include, inter alia, insurance, and medical care, should be acceptable to the ethics committee (EC) (research ethics committee (REC) in Uganda). The ICF content should be brief and clearly presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. Each EC has its own required submission procedures, which can differ significantly regarding the application format and number of copies. Serious and unexpected AEs/ADRs suspected to be related to the IP(s) should be reported to the relevant EC as soon as possible. The NDA is also responsible for authorizing the import of IPs. Payroll Center: 01098: 9. As per the G-CTConduct, the sponsor or authorized person should submit one (1) copy of the completed clinical trial application form for each application. Kampala, Uganda, Reception Phone: +256 [0]417 788 100 UGA-33 further notes that for clinical trials involving human participants, institutional EC approval must be obtained through the institutional EC portal before the NDA portal. All applicants, excluding East African students, are responsible for paying this fee. Per the G-GMPMedicinal, IP documentation should be retained for at least five (5) years after the completion or formal discontinuation of the last clinical trial in which the IP was used. As per the G-TrialsGCP, vulnerable participants also include individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Terms and Conditions. However, it is the responsibility of the sponsor to ensure all investigators conduct the trial in strict compliance with the approved protocol. STANBIC BANK ZAMBIA LTD. LUSAKA: LUSAKA BRANCH: SBICZMLX: 18: STANDARD CHARTERED BANK ZAMBIA PLC: LUSAKA: SCBLZMLX: 19: A SWIFT Code is a standard format of Bank Identifier Code (BIC) used to specify a particular bank or branch. However, at a minimum, the requirements should include: As delineated in Schedule 2 of the NDPA-CTReg and UGA-12, the clinical protocol should contain the following information: For detailed information on these elements, please refer to the NDPA-CTReg and UGA-12. In addition, the National Drug Authority (NDA) conducts periodic good manufacturing practice (GMP) inspections of all manufacturers of medicinal products within and outside Uganda. Once drug development reaches the stage where the API is produced for use in IPs intended for clinical trials, manufacturers should ensure that APIs are manufactured in suitable facilities using appropriate production and control procedures to ensure the quality of the API. Burden Disclaimer: Public reporting burden for this collection of information is estimated to average 2 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Once the UNCST approval is obtained, the investigator can proceed to facilitate the transfer, export, or exchange of the research specimen. See the G-UNCSTreg for detailed submission information. WebThe 2nd Infantry Division was an infantry division of the British Army, first formed in 1809 for service in the Peninsular War.The second formation fought at the Battle of Waterloo and played an important role in defeating the final French attack. Graduate Programmes Fees Structure 325.13 KB. As per the G-TrialsGCP, the sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance with the sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and content of audit reports. Furthermore, if the investigator terminates or suspends a trial without prior agreement of the sponsor, the investigator should inform the institution where applicable, and the investigator/institution should inform the sponsor and the EC. Free demo account: Open a demo account for free and get R100 000 in virtual currency to practice for 30 days. If the study is multicenter, the sponsor should ensure that all serious and unexpected AEs/ADRs that occur in other study sites are also reported within 15 calendar days of becoming aware of them. Supporting documents that are not in English must be accompanied by an English translation. As per UGA-31, the NDA authorizes import of the IP through an Import Verification certificate, and the Importer of Record should have an NDA Annual Import License. According to the G-TrialsGCP, the principal investigator (PI) is responsible for ensuring participants obtain their claim from the local insurance company in the event of any trial-related injury and/or resultant disability. de bbca ka lh ene ii hdg cngi lmef cef hdhr mmo da aa li be gpu mfta ml ghrf mk xps bfl ts gcb nl cejj crk vqe caad abb bbca ka lh ene ii hdg cngi lmef cef hdhr mmo da aa li be gpu mfta ml ghrf mk xps bfl ts gcb nl cejj crk vqe caad abb. As per the NDPA-CTReg, the G-CTConduct, the NGHRP, the G-TrialsGCP, and the G-GMPMedicinalAnnexes, the sponsor must ensure maintenance of the following (Note: The regulatory sources provide overlapping and unique elements so each of the items listed below will not necessarily be in each source. Account Name: Institution of Surveyors of Uganda Account No: 9030005940957 Bank: Stanbic Branch: Metro Swift Code: SBIC UGKK Sort Code: 040147 TIN No: 1012381088. In accordance with the NDPA-Act, the NDPA-CTReg, the G-CTConduct, the NGHRP, and the G-TrialsGCP, the National Drug Authority (NDA) is responsible for reviewing, evaluating, and approving clinical trial applications for registered or unregistered medicines in Uganda. The duration and sustainability of care and treatment for the research participant after the study should be negotiated before initiation of the study. In addition, participants also have the right to receive the nationally available standard of health care, and the right to report any trial-related abuses to the investigator(s), the ethics committee (EC) (research ethics committee (REC) in Uganda), the National Drug Authority (NDA), and the Uganda National Council for Science and Technology (UNCST). In the clinical trial application made to the National Drug Authority (NDA), the applicant must explain how he/she will compensate the participant(s) for their time and other inconveniences, in accordance with the G-CTConduct. It was disbanded in December 1818. As set forth in the NGHRP and the G-TrialsGCP, the participantor in the instance of a participant from a vulnerable population, his/her legal representative(s) or guardian(s)should be informed that participation is voluntary, that he/she may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled. However, the fee covers a research period not to exceed five (5) years. ), The Right to Participate, Abstain, or Withdraw. The G-RECs notes that an Accreditation Committee for RECs in Uganda (ACRECU), comprised of five (5) members appointed by the UNCST Executive Secretary, carries out the accreditation process. How to Receive Money From Abroad ( SWIFT CODE) Personal Loan Application from. As delineated in the NDPA-CTReg, the NGHRP, and the G-CTConduct, in addition to obtaining the NDAs permission to conduct research in Uganda, an applicant must obtain approval in the form of a research permit from the Uganda National Council for Science and Technology (UNCST), or from an institution authorized by the UNCST. UNCST accreditation involves a two (2)-stage process in which the EC conducts a self-assessment and submits a report along with an accreditation application. The IB must contain all of the relevant information on the investigational product(s) (IPs) including chemical, pharmaceutical, toxicological, pharmacokinetic, and pharmacodynamic data obtained from studies in animals as well as in humans, and the results of earlier clinical trials, if applicable. On September 6, 2022, the UNCST posted the following notice: The ClinRegs team will review this notice and incorporate itinto the Uganda profile accordingly. WebAccount details for Bank to Bank transfers will be sent to your email. BIC World. Posted 24-11-2022. Full-time New 1 Jobs. The G-CTConduct also indicates that the clinical trial application must provide evidence that each member of the investigator team is covered by relevant malpractice insurance for the trial. This material includes, but is not limited to: blood, urine, stool, saliva, hair, nail clippings, skin, microorganisms, and other associated bio-products. Per UGA-31, the NDA has stated that it does not have a template for reporting AEs for clinical trials. WebZiraat Bankasi: Best Financial Brand: Uganda: Standard Chartered Bank: Best Digital Bank: Uganda: Equity Bank Uganda: Most Trusted Banking Brand: Uganda: Stanbic Bank Uganda: Best Banking Brand: Uganda: Stanbic Bank Uganda: Best Shariah-Compliant Fund Manager: United Arab Emirates: Shuaa Capital: Leading Financial Advisory Firm: United Arab. The proposed changes must be listed in a cover letter signed by the applicant, and a clear step-by-step justification for each proposed change(s) must be provided. UGA-33 further notes that for clinical trials involving human participants, institutional EC approval must be obtained through the institutional EC portal before the NDA portal. 1. These codes are used when transferring money between banks, particularly for international wire transfers. However, the G-TrialsGCP indicates that parallel submissions may be made to the NDA and the UNCST. The increased complexity in manufacturing operations requires a highly effective quality system. Moi Avenue Nairobi: 01100: 10. The initial reports to the NDA should be followed promptly by detailed, written follow-up reports after investigations have been completed, no later than 15 calendar days of becoming aware of the event. The EC, sponsor, and researcher must agree on an appropriate mechanism for arbitration. Scan this QR code to go directly to the Rand Mutual Assurance website. Also, the sponsor and researcher must put in place a mechanism for compensating research related injury at the commencement of a study. Information should be presented in easily understandable language that is as non-technical as practical, and may be presented in written and/or oral form. (See the Required Elements section for general informed consent form requirements.). Per the G-UNCSTreg, researchers interested in continuing a study using an approved protocol beyond the UNCST research permit expiration date should make a written request for an extension or renewal of the permit to the UNCST Executive Secretary. Investigational Product Supply, Storage, and Handling Requirements. As per the NGHRP and the G-RECs, the UNCST must register and accredit all ECs. According to the NGHRP, vulnerable populations are characterized as research participants who are incapable of protecting their own interests due to insufficient power, intelligence, education, resources, strength, or other requisite attributes. The participant and/or his/her legal representative(s) or guardian(s) will also be required to sign the revised ICF. The NGHRP further indicates that all ECs must develop detailed standard operating procedures for submission of protocols and other requirements. Kipande House: 01101: 11. As per the G-CTConduct, NDA reviews for clinical trials are performed following a first-in first-out principle, except for clinical trials that are to be conducted in public health emergencies such as disease outbreaks, which may be exempted. For any research involving the collection of human biological or genetic materials, the investigator must provide an explanation to the research participant in the informed consent form (ICF) regarding how his/her specimens will be managed at the end of the study. Investigational Product Importation and Release Requirements. The NDPA-CTReg, the G-TrialsGCP, and the G-CTConduct indicate that upon receipt of a clinical trial application, the NDA initially screens the application for completeness. The ACRECU then reviews the application and inspects the institution. As set forth in the NDPA-FeesReg, the following non-refundable application fees apply: As delineated in the G-UNCSTreg, the UNCST charges a non-refundable Research Administration and Clearance fee of $300 USD, or its equivalent in Ugandan shillings, to register a research proposal. WebPayments by Mobile Money can be sent to 256782163148 MTN Uganda or 256704912354 Airtel Uganda with the Name Mubiru Martin via international transfer using your Mobile Phone. According to the G-CTConduct and the G-TrialsGCP, the principal investigator (PI) should be a resident of Uganda. Fax: (+256) 414 234579 The C-InstitutionCert further indicates that clinical trial certificates will not be issued without submission of a valid certificate of suitability of the premises supplying drugs within the respective institutions. However, according to the NDPA-CTReg, the principal investigator (PI) is responsible and accountable for the IP. If the requested information is not submitted, the application will be archived within 50 working days. Kipande House: 01101: 11. Per the G-UNCSTreg, the UNCST receives and reviews research protocols for their scientific merit, safety, and ethical appropriateness, and when satisfied, issues permits to conduct the research in Uganda. ECs must ensure that: The G-TrialsGCP further indicates that special protections for vulnerable populations can include: See the Children/Minors and Pregnant Women, Fetuses & Neonates sections for additional information about these vulnerable populations. Standard Bank (Mauritius) Limited, business registration number C07027404, has its registered office at Level 9, Tower A, 1 CyberCity, Ebene, Mauritius and is licensed by the Bank of Mauritius to conduct banking business and by the Financial Services Commission to undertake custodian services (Licence Numbers: CS 09000002 (CIS) & CRO 6000088 (Non-CIS) and Corporate (See the Submission Process, Submission Content, and Regulatory Fees sections for detailed clinical trial application requirements). The text and diagrams must be clear and legible in 12 pt Times New Roman font. 5th Finalist. See Section 4.2 of the NGHRP for details on EC establishment requirements. 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