Prior to the patient�s participation in the study, the written informed consent form must be signed and personally dated by the patient and by the clinician who conducted the informed consent discussion (Ref. The definition of a serious adverse event is one that fulfils at least one of the following criteria: Is fatal- results in death Is life threatening Requires inpatient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity OR Is a congenital anomaly/birth defect The definition of a suspected unexpected serious adverse reaction (SUSAR) is a serious adverse event that is thought to be possibly or definitely related to the study drug. Monitoring and Audit Upon request of the monitor, auditor, Sponsor, R&D, REC, MHRA or other regulatory authority, the Investigator should make available for direct access all requested study-related records. Papworth Industries was the name given to the manufacturing arm of Papworth Village Settlement, a Cambridgeshire colony for sufferers of tuberculosis founded in 1916. � Ơ �!
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p. 139. Data Collection Data Collection Form Completion The Investigator should ensure the accuracy, completeness, legibility and timeliness of the data recorded in the data collection forms (DCFs) and in all required reports to e.g. The project data will monitored by the Research Officer (insert time interval e.g. SUSAR reports to be submitted to the main REC (timelines to be specified) Expected SAEs need to be reported to the Main REC in the annual REC report; the REC who performed the locality assessment does not need to be informed.

The name Pendragon was dropped in favour of Papworth Travel Goods, still the brand name for a range of luggage and leather goods made by Swaine Adeney Brigg. In the four years since the ‘T’–Planters Club was founded and when it closed in 1990 the total sum raised by the members and friends was £109,917. By 1937 output had reached thirty thousand pieces of luggage a year and the new factory was bursting at the seams. [27], Papworth Hospital was named by the Health Service Journal as one of the top hundred NHS trusts to work for in 2015.

The first two (or insert an appropriate number) patients will be monitored in full. [10] In February 1980, 23 year old male nurse Paul Coffey became Britain's thirteenth heart transplant patient, when he was given the heart of a woman who had died in a car crash, by surgeons at Papworth Hospital. [14], In December 2013 it was announced that the hospital would move to the Cambridge Biomedical Campus next to Addenbrooke's Hospital in Cambridge.

[9], During the Second World War, the carpentry section of the Industries switched mainly to the making of aircraft parts. Errors and Corrections Any change or correction to the DCF should be dated, initialled, and explained (if necessary) and should not obscure the original entry (i.e.


i [5] In 1919 further industrial facilities were added, among them: a printing shop; a bookbindery; and a trunk-making workshop, this latter the origin of Pendragon Travel Goods.

Royal Papworth Hospital NHS Foundation Trust Royal Papworth Charity Papworth Road Cambridge Biomedical Campus Cambridge CB2 0AY. At that time it had 1677 full-time equivalent staff and a sickness absence rate of 3.63%. Table 1 Visit Schedule Visit NumberVisit nVisit n+1Visit n+2Visit n+3Visit n+4Visit n+5Time interval of Visite.g.
Trial Overview Primary Research Question Study Design This section should include: A description of the type/design of trial to be conducted e.g. [25], On 2 November 2007 it was announced that Papworth Hospital would suspend heart transplant activities while an investigation was undertaken into an unexplained rise in recipient mortality rates. It became the first NHS hospital trust to ever be awarded the top mark of 'outstanding' in each of the five key inspection domains. week -1e.g.

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Data Analysis and Document Retention Sample Size Statistical Analysis Economical Analysis Retention of Documents 4. Protocol Non-CTIMP Page PAGE 1 of NUMPAGES 10 Version 2.0 Review Date: December 2021 Protocol Non-CTIMP Page PAGE 2 of NUMPAGES 10 Version 2.0 Review Date: December 2021 ! " It became a church hall after a new brick church was built next to it in 1954.

Prior to the patient�s participation in the study, the written informed consent form must be signed and personally dated by the patient and by the clinician who conducted the informed consent discussion (Ref. The definition of a serious adverse event is one that fulfils at least one of the following criteria: Is fatal- results in death Is life threatening Requires inpatient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity OR Is a congenital anomaly/birth defect The definition of a suspected unexpected serious adverse reaction (SUSAR) is a serious adverse event that is thought to be possibly or definitely related to the study drug. Monitoring and Audit Upon request of the monitor, auditor, Sponsor, R&D, REC, MHRA or other regulatory authority, the Investigator should make available for direct access all requested study-related records. Papworth Industries was the name given to the manufacturing arm of Papworth Village Settlement, a Cambridgeshire colony for sufferers of tuberculosis founded in 1916. � Ơ �!

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