Regulatory Rapporteur style guide

AAA

abbreviations/acronyms

• No full stops in abbreviations, or between initials: EU, US, ICH, NICE, eg, ie, Regulation No 10101, Michael S Brown, B Braun Medical, etc.

• To avoid awkward breaks across two lines, eg, between Phase I; Regulation No; Article 1; Dr Smith; use non-break space – CTRL + SHIFT + Spacebar

• Do not spell out: EU, FDA, ICH, US, UK. Prefer to explain but not spell out other common regulatory abbreviations, along the lines of, eg: ‘the UK regulator, the MHRA’; ‘China’s regulatory agency, the CFDA’; ‘the US industry trade association, PhRMA’

• Spell out other abbreviations on first mention, eg: marketing authorisation (MA); European Medicines Agency (EMA); decentralised procedure (DCP); standard operating procedures (SOPs).

• Note: The FDA (not FDA); The WHO (not WHO)

accents

Use accents on French, German, Spanish and Irish Gaelic words (but not anglicised French words such as cafe, unless the word may be misread, eg, use exposé, résumé)

Act/act

Cap up initial when using full name, eg, Food and Drug Administration Amendments Act (FDAAA); but l/c on second reference, eg, ‘the act’, and when speaking in more general terms, eg, ‘we need a revised freedom of information act’

advanced therapies

l/c, but Advanced Therapy Regulation Note: Full title of these products – “advanced therapy medicinal products (ATMPs)”

adverbs

No hyphens after adverbs ending in -ly, eg a hotly disputed decision, a constantly evolving journal, genetically modified food, etc; but hyphens are needed with short and common adverbs, eg, illprepared submission; well-known Regulation; hard-won legislation

adviser

not advisor

affect/effect

Example: rules in the style guide had no effect (noun) on the number of mistakes; the number of mistakes was not affected (verb) by rules in the style guide; we hope to effect (verb) a change in this

ageing,

not aging write: aged 40–60 years [not ‘age’ and not ‘to’; use en-dash (long hyphen “–”), not standard hyphen] (See also: “hyphens”]

agency

l/c, including, for example, ‘the Greek agency, EOF’, unless talking about a specific agency with the word ‘agency’ in its title

aggravate

to make worse, not to annoy

ahead of

avoid: use before or in advance of

all right

is right; ‘alright’ is not all right

American universities Take care: ‘University of X’ is not the same as ‘X University’ – most US states have two large public universities, eg, University of Kentucky and Kentucky State University, University of Illinois/Illinois State University, etc. NB: Check spellings, eg, Johns Hopkins University, not John Hopkins; Stanford University, not Stamford.

amid

not amidst

among

not amongst

among or between?

‘between’ is not limited to two parties. It is appropriate when the relationship is essentially reciprocal, eg: differences between the members of ICH; harmonisation between the ICH countries. ‘Among’ is used for distributive relationships: shared among the EU member states, etc

ampersand [&]

use in company names/conference titles/publication names only when the originator does, eg: Merck & Co; Johnson & Johnson; Annual Conference on Regulatory Affairs & Pharmacovigilance. Otherwise, spell out

anticipate

take action in expectation of; not synonymous with expect

anticancers

no hyphen

antidepressants

no hyphen

apostrophes

Use apostrophes in: five years’ experience; two days’ time; 12 years’ exclusivity; where the time period (two days) modifies a noun (time), but not in nine months pregnant or three weeks old, where the time period is adverbial (modifying an adjective such as pregnant or old) – if in doubt, test with a singular such as one day’s time, one month pregnant

Apostrophes matter for clarity – consider these four phrases, each of which means something different:

my colleague’s patient’s medications [ie, a patient of my colleague]

my colleague’s patients’ medications [ie, patients of my colleague]

my colleagues’ patient’s medications [ie, a patient of my colleagues]

my colleagues’ patients’ medications [ie, patients of my colleagues]

appendix

plural, appendices

approach

avoid where possible, eg, ‘a proactive approach to pharmacovigilance’ becomes ‘proactive pharmacovigilance’

around

(meaning: approximately) use instead of ‘about’: eg, ‘around US$900 million’ or ‘around 2,000 patients’

author listings in author boxes/references

author boxes – list all authors

author box listing details – Author full name (no title); job title; organisation, county/state; country. (No web address.)

authors in references – name only three before ‘et al’ as a general rule; et al in italics

author names

No titles, or degree status, eg, delete ‘Dr’, ‘Professor’, ‘PhD’, ‘MSc’, both on Contents Page and in Author boxes. Simply use: John Brown, Mary Smith. [But always use titles in text when referring to people who are not the authors, eg, speakers in Meeting Reports]

average, mean and median

Although we loosely refer to the ‘average’ in many contexts (eg, cost of developing a drug), there are two useful averages worth distinguishing.

What is commonly known as the average is the mean: everyone’s wages are added up and divided by the number of wage earners.

The median is described as ‘the value below which 50% of employees fall’, ie, it is the wage earned by the middle person when everyone’s wages are lined up from smallest to largest. (For even numbers there are two middle people, but you calculate the mean average of their two wages.) The median is often a more useful guide than the mean, which can be distorted by figures at one extreme or the other.

awards, prizes, medals

generally l/c, eg: Nobel peace prize, Fields medal (exception: TOPRA’s Awards for Regulatory Excellence); note that awards categories are l/c, eg, ‘Company X won the best drug delivery programme’

BBB

bacteria

plural of bacterium, so ‘the bacteria are’

before

rather than ‘prior to…’

benefited, benefiting

Betaferon

TM; the generic term for the drug is lower-case initial letter, interferon-beta 1b

big, large

both preferable to massive, giant, mammoth

billion

one thousand million, not one million million spell out in full, six billion people, US$10 billion, etc

Bombay

now Mumbai

newspaper and journal titles

Italicised, both in body text and in references: The Lancet, New England Medical Journal, The Washington Post

brackets in speech

‘Square brackets,’ the grammarian said, ‘are used in direct quotes when an interpolation [a note from the writer, not uttered by the speaker] is added to provide essential information.’

bullet points (also known as blobs) should normally appear in Regulatory Rapporteur like this:

• Initial cap at start and no full stop until end of final bullet

• Bullets full out, then indented to text.

but, however

often redundant, and increasingly wrongly used to connect two compatible statements; ‘in contrast, however, …’ is tautologous

CCC

capitals

here are the main principles:

• job designations/titles: all l/c eg, prime minister, US secretary of state, editor of Regulatory Rapporteur

• British government departments of state, when using the proper name: All initial caps eg, Home Office, Foreign Office, Ministry of Defence (MoD on second mention). But when not the proper name, use l/c, eg, state department, health ministry

• universities and colleges of further and higher education: caps for institution, l/c for departments [in body copy] eg, Cambridge University department of medicine, Oregon State University, Free University of Berlin, University of Queensland school of medicine

• Common RA industry terms

Always l/c, followed by abbreviation at first mention, eg, investigational medicinal product (IMP), investigational medicinal product dossier (IMPD)

centralised procedure (CP)

lower case initial letters followed by abbreviation in brackets at first mention

chair or chairperson

not chairman or chairwoman

clinical trials 

Phase I, II, III not Phase 1, 2, 3

clinical trial application (l/c)

sometimes abbreviated to CTA but care is needed as CTA can also refer to clinical trial authorisation or clinical trial assay – check with author if unclear

Clinical Trials Directive (initial caps)

collective nouns nouns such as committee, company, team, regulatory agency, take a singular verb or pronoun when thought of as a single unit, but a plural verb or pronoun when thought of as a collection of individuals:

the agency gave its unanimous approval to the plans;

the agency had a coffee break after their working lunch

the agency gave its thoughts on the new legislation;

the agency were sitting in the conference room, sharing their thoughts

colon

(punctuation) initial cap follows a colon in headlines, but l/c in the main body text

commas

‘The associate editor, John Brown, is an aficionado of house style guides’ – correct (commas) if there is only one; ‘The associate editor John Brown is an aficionado of house style guides’ – correct (no commas) if there is more than one associate editor.

common technical document (CTD) (not “dossier”)

but authors may use this abbreviation to mean Clinical Trials Directive – check with author if unclear

He/she commented

avoid: prefer ‘he/she said’

companies

always in the singular, eg, GlaxoSmithKline is launching a new product − always spell out in full, eg, GlaxoSmithKline not Glaxo, or GSK.

competent authority(ies)

l/c unless talking about a specific CA, eg, the UK Competent Authority

Commission, as in European Commission

cap up initial C when using “the Commission noted…” (Always write “European Commission” at first mention)

compare(d) to/with

(see explanation below, but will almost always be ‘compared with’ in Regulatory Rapporteur copy)

• the former means liken to, the latter means make a comparison; so unless you are specifically likening someone or something to someone or something else, use compare with: the CEO compared himself to Albert Einstein because he believed he was like Einstein; I might compare him with Einstein to assess their relative merits

comprise

it consists of; it comprises (‘comprise of’ is wrong)

conflicts of interest

(not conflicts of interests, or conflict of interests)

convince/persuade

having convinced someone of the facts, you might persuade them to do something

cooperate, cooperation, cooperative

no hyphen

coordinate

no hyphen

countries/regions

• UK (not Great Britain, Britain, GB)

• US (not USA, America)

• the Netherlands (not The Netherlands)

• Holland: do not use when you mean the Netherlands (of which it is a region)

• Colombia vs Columbia: South American country of Colombia vs District of Columbia (Washington DC) and Columbia University (New York)

• Europe includes the UK, so don’t say, for example, something is common ‘in Europe’ unless it is common in the UK as well; to distinguish between the UK and the rest of Europe, the phrase ‘continental Europe’ can be used (eg, regulations between the UK and continental Europe can differ); other differentiators include “the EU” (after Brexit, when the UK is no longer in the EU), central Europe, eastern Europe, western Europe, etc.

• Ukraine (not ‘the Ukraine’); adjective Ukrainian

• Oceania, a preferable term to Australasia, (see Oceania for further definition)

currencies

• Abbreviate dollars like this: US$50 (US dollars); A$50 (Australian dollars); HK$50 (Hong Kong dollars; no space between currency signs and figures)

• Convert all UK sterling amounts to US$ in brackets at first mention, eg, £50,000 (US$73,700)

• Use symbols, not words, when depicting sums of money, for: £, $, €, ¥ [Note: ¥ is the currency symbol used for the Japanese yen (JPY) and the Chinese yuan (CNY)]

• When the whole word is used, it is l/c: euro, pound, sterling, yen, dong, etc.

DDD

data

takes a plural verb: the data were checked

dates

• days of the week are not normally used in dates

• the day number always comes before the month: 1 January 2018

• 1980s, 1990s (no apostrophe, and no short form, ie, 90’s)

• 21st century; fourth century BC; AD2006 but 1000BC

decentralised procedure (DCP)

lower case initial letters

defuse

render harmless; diffuse = spread around

developing countries

use this term in preference to ‘third world’

different from

not different to or than

direct speech

People we interview are allowed to speak in their own, not necessarily Regulatory Rapporteur’s, style, but be sensitive: do not, for example, expose someone to ridicule for dialect or grammatical errors

disk (computers)

not disc

drug companies, drugmakers

drug names

• Brand name capped up followed by generic name in brackets, eg: Avastin (bevacizumab).

• Do not use registered trademark® or ™ symbols following the brand names

• Typically use European brand name vs US (eg, Glivec vs Gleevec), unless it is most commonly known by its US name.

due to/owing to

For example, compare: ‘It was difficult to assess the changes due to outside factors,’ with: ‘It was difficult to assess the changes owing to outside factors’. The first says the changes that were a result of outside factors were difficult to assess, the second says outside factors made the changes difficult to assess (if in doubt, because of can be substituted for owing to, but not due to)

EEE

earpiece/running head

Cap up first initial only in earpieces/running heads

E coli

as with other taxonomic names, italicise in copy but roman in headlines and standfirsts; no full stop [use non-break space to keep together]

eCTD

(no hyphen)

efficacy vs effectiveness*

• Efficacy: The extent to which an intervention does more good than harm under ideal circumstances.

• Relative efficacy: The extent to which an intervention does more good than harm, under ideal circumstances, compared with one or more alternative interventions.

• Effectiveness: The extent to which an intervention does more good than harm when provided under the usual circumstances of healthcare practice.

• Relative effectiveness (aka comparative effectiveness, US): The extent to which an intervention does more good than harm compared with one or more intervention alternatives for achieving the desired results when provided under the usual circumstances of healthcare practice.

*Definitions developed by the EU High Level Pharmaceutical Forum, ‘Core principles on relative effectiveness, Final report 2005–2008’. http://ec.europa.eu/pharmaforum/docs/ev_20081002_frep_en.pdf (accessed March 2011).

ellipses […]

use spaces before and after ellipses, and three dots (with no spaces between them), when parts of a direct speech are cut, eg: ‘She told me she didn’t want to enrol on the trial … her main concern was leaving her children’

email

(no hyphen)

endpoint

(no hyphen)

enrol, enrolling, enrolment

EU

European Union (no need to spell out at first mention); formerly EC (European Community); before that EEC (European Economic Community)

EU presidents

There are three, so don’t say ‘EU president’ or ‘president of the union’ without making clear which you mean: president of the European Commission, president of the European Parliament, or holder of the rotating presidency (technically ‘president in office of the council of the European Union’), which rotates among the EU member states every six months

EudraCT

database of all clinical trials commencing in the EC from 1 May 2004 onwards

EudraLex

the sets of rules and regulations governing medicinal products in the EU (note cap “L”)

EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance)

(note cap “V”) the European data processing network and management system for reporting and evaluation of suspected adverse reactions during drug development and following the marketing authorisation of medicinal products in the European Economic Area (EEA).

euro

(l/c) currency; plural euros and cents

FFF

FDA

‘US FDA’ not just FDA at first mention. Add ‘the’ in front, (Americans use ‘FDA says’, rather than ‘the FDA says’)

fewer or less?

fewer means smaller in number, eg fewer drugs; less means smaller in quantity, eg less drugs

first, second, third

rather than firstly, secondly, thirdly

figures/tables/graphs/diagrams

• Must be referred to in the text at appropriate point, eg, (see Figure 1) – and in the right order.

• when referring to a sidebar or box of text, write “(see Box)”.

• colon after figure number, eg, Figure 1: Xxxxxxxxxxxxx; title in lower case (after first initial) except where it contains words that are capitalised anyway; no full stop

• check for coherence in a table (for example, that numbers in columns add up to the total shown) and for consistency with references to the Figures in the text

• ensure each axis is labelled to indicate what the figures represent (eg: ‘number of trials’, ‘number of patients’)

focused, focusing

foetus

not fetus

fulfil, fulfilling, fulfilment

GGG

G8

Canada, France, Germany, Italy, Japan, the UK, the US and Russia

Geographical areas, caps vs l/c

• l/c for regions: the north, the south of England, the south-west, north-east England; the same applies to geopolitical areas: the west, western Europe, far east, south-east Asia, central America etc.

• cap up, though, when part of the name of a county (West Sussex, East Riding) or province (East Java, North Sulawesi, etc)

• note the following: West Country, Middle East, Latin America, North America

government

l/c in all contexts and all countries

Great Britain vs the UK

England, Wales and Scotland; if including Northern Ireland, use the UK

Guideline(s)

• Cap up initial if referring to a specific Guideline; l/c if referring to guidelines in general

• within article text, guideline names should be in double quote marks; title written in l/c after initial cap on first word, apart from words that are capitalised anyway.

HHH

headlines/crossheads/contents titles:

Cap up initial of first word only

• Cap follows a colon (though this is not the case in the main body text)

headquarters

can be used as a singular (‘a large headquarters’) or plural (‘our headquarters are in London’); HQ, however, takes the singular

Heads of Medicines Agencies

(all plural)

healthcare

(one word)

homogeneous vs homogenous

homogeneous = uniform, of the same kind;

homogenous (biology) = having a common descent; the latter is often misspelt/misused for the former

Huntington’s disease

(not Huntingdon’s) formerly known as Huntington’s chorea

hyphens

There are three lengths of what can be called dashes or hyphens: hyphen (-), en-dash (–) and emdash (—). [Note: en-dash so called because it’s the length of an ‘n’; m-dash is the length of an ‘m’.]

en-dash is used to represent the word “to”, eg, 12–14 January; benefit–risk ratio. Note no spaces between the figures/words. It is also used to separate parenthetical statements – such as this one – in which case spaces should separate the en-dash from the words around it. To create an endash in Word, use CTRL + minus sign on number pad. In InDesign, it’s ALT + hyphen. em-dash is not house style. Convert any em-dashes to en-dashes.

When to use/not to use hyphens: Our style is to use one word wherever possible to avoid cluttering up text (particularly as the printing process breaks already-hyphenated words at the end of lines). This is a widespread trend in written English. Inventions, ideas and new concepts often begin life as two words, then become hyphenated, before finally becoming accepted as one word. ‘Wire-less’ and ‘down-stairs’ were once hyphenated. As examples, words such as website, laptop and email, should now all be one word (and l/c) in our publications, as should thinktank, clearcut, longlist, shortlist.

Prefixes such as macro, mega, micro, mini, multi, over, super and under rarely need hyphens. Hyphens should, however, be used to form short compound adjectives, eg, two-tier health service, ten-year patent, 19th-century physician, etc.

Do not use hyphens after adverbs ending in -ly, eg, politically naive, wholly owned, but when an adverb is also an adjective (eg, hard), the hyphen is required to avoid ambiguity – it’s not a hard, pressed scientist, but a hard-pressed one; an ill-prepared report, rather than an ill, prepared one. Use hyphens with short and common adverbs: much-needed treatment, well-established principle (note though that in the construction ‘the principle is well established’ there is no need to hyphenate). Hyphenate ‘side-effect’. Hyphenate if followed by vowel, not if consonant eg, re-examine but rerun. Exceptions are coordinate/coodinator; cooperate/cooperative.

Do not hyphenate crossover, antidepressant, gastrointestinal, lifecycle, dataset, multicentre, heart rate, healthcare, website, multisite, multidisciplinary.

Do hyphenate electronic shortening only when it is unclear, eg, eLearning, eCTD, but e-commerce

Do hyphenate post-approval, hold-up, post-marketing, sub-anything, real-world, non-compliance, long-term (in, eg, long-term commitment; but NOT in, eg, in the long term) When referring to ranges, use en-dash (ie CTRL + minus sign on number pad), for instance, 30– 40.

III

ICH-GCP

No need to spell out in full

ie,

no full stops, but comma follows, ie, like this (also eg)

immune to,

not immune from

impracticable vs impractical:

impracticable = impossible,

it cannot be done impractical = possible in theory but not workable at the moment

inadmissible,

not “-able”

Indian placenames the former Bombay is now known as Mumbai, Madras is now Chennai, Calcutta is now Kolkata and Bangalore is now Bengalooru

infer/imply

to infer is to deduce something from evidence; to imply is to hint at something (and wait for someone to infer it)

inpatient, outpatient

no hyphens

install, instalment

instil, instilled, instilling

internet

 l/c

introductory phrases

such as ‘However’, ‘Nonetheless’, ‘Instead’, should all be followed by a comma

-ise

not -ize at end of word, eg, maximise, synthesise

italics

-Use for journals/monographs/books titles. No quotation marks. Cap up initials of each word.

- All Latin words and phrases, eg, et al, ad hoc, in vitro, in vivo, in silico (use non-break space to keep words together)

its, it’s

(never its’)

If you can substitute the word with “it is” or “it has” then you want the contraction “it’s”

− It’s a new clinical trial

−It’s been more than a year If you can replace the word with “his” or “her” and it makes sense, then you want the possessive “its”

− The organisation is strong, but its rules are weak

− The world is its oyster

JJJ

Johns Hopkins University

not John Hopkins judgment

KKK

Keywords:

Cap up first initial of each key word or phrase, semi-colon between each, full stop on final keyword, eg:

Biologicals; Antibody drugs; Carcinogenicity; Cellular proliferation assays.

kilogram/s, kilojoule/s, kilometre/s, kilowatt/s

abbreviate as kg, kJ, km, kW

LLL

labelled, labelling

led

use this as past tense of the verb ‘lead’

less/fewer

less means smaller in quantity, eg, less drug; fewer means smaller in number, eg, fewer drugs

lifecycle

(one word)

lifelong

(one word)

leukaemia

licence

noun

license

verb, a company might apply for a pharmaceutical industry licence; they might be ready to license their company; or they might have an understanding of pharmaceutical licensing

light year

a measure of distance, not time

like vs such as

‘like’ excludes; ‘such as’ includes: ‘Drugs like aspirin are highly effective’ suggests the writer has in mind, say, ibuprofen or codeine; the author actually means ‘drugs such as aspirin’.

liquefy

not liquify 

lists, in text

(the Oxford comma)

the Oxford comma is a comma before the final ‘and’ in lists: straightforward lists (he was prescribed with ibuprofen, diuretics and bed-rest) do not need one, but sometimes it can help the reader (the patient had cereal, bacon, eggs, toast and honey, and tea)

MMM

Médecins sans Frontières

international medical aid charity (don’t describe it as French)

Medicaid, Medicare

both US federal health insurance programmes, Medicare primarily covers people over 65 and has no financial requirements for eligibility; Medicaid is targeted at those on low incomes

member states

(do not cap up initial letters). Abbreviate to MS, even when plural (eg, several MS have adopted…)

more than

(not over) eg, more than 250,000 patients; more than US$1 million

multicentre

no hyphen

multisite [trials]

no hyphen

mutual recognition procedure (MRP)

lower case initial letters

myriad

a large, unspecified number; use as an adjective (there are myriad patients in the trial) or a noun (there is a myriad of patients in the trial), but not ‘myriads of’

NNN

names, in reporting

• Prominent figures can just be named in articles, with their function at second mention: ‘Thomas Lönngren said yesterday… ‘ (first mention); ‘the Agency’s executive director added…’ (subsequent mentions).

• Where it is thought necessary to explain who someone is, write: ‘Jan Lundberg, AstraZeneca’s executive vice-president, said’, or: ‘AstraZeneca’s executive vice-president, discovery research, Jan Lundberg, said’.

• In such cases, the commas around the name indicate there is only one person in the position, so write ‘the Tory leader, Theresa May, said’ (only one person in the job), but ‘the former Tory leader David Cameron said’ (there have been many).

National Institute for Health and Care Excellence (NICE)

‘NICE’ after first mention

the Netherlands

(not The Netherlands) not Holland, which is only part of the country; use Dutch as the adjective

nonclinical

(no hyphen) (do not use ‘preclinical’, always change to nonclinical)

notified body (NB)

l/c unless talking about a specific notified body, eg, the UK Notified Body

numbers/numerals

Numbers one to ten are written out, 11 upwards in numerals.

Except:

•With abbreviations: 5mg, £4.50

•In titles: 2nd annual meeting of…

•In dates: 1 January 2018 Numbers over a thousand have a comma: 5,000 Millions, billions – use the word, eg: ‘Three million sufferers worldwide…’

OOO

Oceania

a preferable term to Australasia, it is sometimes divided into Near Oceania and Remote Oceania, and comprises, according to the UN:

Australia/New Zealand

Melanesia

(Fiji, New Caledonia, Papua New Guinea, Solomon Islands, Vanuatu)

Micronesia

(Guam, Kiribati, Marshall Islands, Federated States of Micronesia, Nauru, Northern Mariana Islands, Palau)

Polynesia

(American Samoa, Cook Islands, French Polynesia, Niue, Pitcairn, Samoa, Tokelau, Tonga, Tuvalu, Wallis and Futuna Islands)

Often

rather than ‘frequently’

one in six, one in 12, etc

should be treated as plural. Compare ‘more than one in six COPD sufferers is 65 or older …’ with ‘more than one in six COPD sufferers are 65 or older …’. Grammatically, we are talking not about the noun ‘one’ but the noun phrase ‘one in six’, signifying a group of people, ie, the phrase represents a proportion. Equally, ‘17%’ or ‘one-sixth’, take plural verbs. ‘Two out of every seven’ and ‘three out of 10’ take plurals too.

organisations

always in the singular, eg, TOPRA is an organisation for regulatory affairs professionals. It has members worldwide…

PPP

paradigm, paradigm shift

avoid like the plague! Where appropriate, try using: new strategy, new programme, new framework, ‘change in strategy’, etc.

past vs last:

‘In the past 15 years…’ not ‘last’

per cent, %

(two words) write in full in text unless used in relation to specification limits (eg, ±5%), stability conditions (eg, 25°C/65%RH), confidence intervals (eg, 95% confidence interval), or strength of a product (eg, Product X 0.5% nasal spray); % symbol to be used in tables

physicochemical

(no hyphen)

Phase I, II, III, IV (not phase and not 1, 2, 3, 4).

Note: when writing, keep together by using non-break space [CTRL + SHIFT + Spacebar on PCs; APPLE + Spacebar on Macs]

pipeline

(one word)

planning

not ‘forward planning’ (tautological)

practice

noun;

practise

verb

preventive

not preventative

primary care trusts

(l/c)

principal vs principle

principal = first in importance;

principle = standard of conduct programme for computer software and clinical trial programme (unless part of a US-named programme, eg, the US FDA’s Medical Device Single Audit Program)

publications

(see References for fuller details) Italicise names of all publications. Single quote marks around article title.

publicly,

not publically

QQQ

Quality by Design (QbD)

Quotation marks (always double quotemarks):

• Comma before a quote (or colon if lengthy quote); cap up initial of first word, eg: Dr Brown said, “In hypertension, the goal is to reduce mortality,” although she agreed there were other useful endpoints.

• With a full quote, all punctuation is placed inside the quote marks: “In hypertension, the goal is to reduce mortality.”

• For part of a quote, punctuation is placed outside the quote marks: The patient said she was “in moderate pain” following the operation.

• If most of the sentence is a quote, but perhaps starts with an attribution, put punctuation inside end quote, eg: The research team’s director said, “In hypertension, the goal is to reduce mortality.”

• For a quote within a quote, use ‘single’ quotation marks.

Quote boxes/pull quotes, layout

Aligned left in a RH column and right in a LH column. Centred in a central column. No full stop. Italicised. No more than six lines. Use opening and closing quote marks only if the extract is direct speech in the body text, or if it is an opinion piece.

RRR

References

Reference numbers in the body text are placed outside the punctuation, and with no space.

(Please ensure reference numbers are appropriately located within the body text). Reference listings style as follows:

1. M Bowman, P David. ‘Changes in drug prescribing patterns related to commercial company funding of continuing medical education’, Journal of Continuing Education in the Health Professions, 8(2), pp13–20, 1998.

The above reference tells us it is Volume 8, Issue 2, pages 13–20. For page numbers, write out each number in full eg, pp1126–1129 rather than pp1126–29. Double ‘p’ for page if more than one page, just one if only one (eg, p7).

If reference includes a URL, it follows the date, should be in brackets and a full stop follows the closing bracket. The date the website was accessed should be given in its own brackets, eg, (accessed 1 January 2016).

regulatory affairs

(l/c)

regulatory affairs professional

(l/c)

Regulatory Affairs Professionals Society (RAPS)

cap up initials regulatory agency

(l/c, including when talking about a specific agency, eg, the Greek regulatory agency)

Regulatory Rapporteur

not the Regulatory Rapporteur

Always in italics (when fonts allow), ie, Regulatory Rapporteur

‘with regard to’ or ‘with regards to’?

with regard to (no ‘s’) means about or concerning. The other expression meaning the same thing is ‘as regards’. [‘Regards to’ (with ‘s’) relates to sending your regards (good wishes) to someone.]

Regulation(s)

cap up initial if a specific Regulation; l/c if referring to regulations in general

SSS

scientific advice

(l/c)

side-effect

(hyphenate)

Spaces/spacing

• Remove double spaces throughout document (often used following full stops by authors) – use ‘find and replace’ [CTRL+F].

• Spacing between words – use non-break space for: Phase I; Article 1; Dr Smith; etc Speciality vs specialty Use ‘specialty’ when describing an area of expertise, eg, Dr Johnson’s specialty is nanotechnology.

Spelling

• Always use English spelling unless giving the name of, eg, a US regulation/law when original US spelling should be used, eg, FDA Modernization Act.

• Use original Latin spellings (ie, UK spellings) eg, paediatrics; oestrogen; foetus

• UK: -ising, -isation (not izing, -ization), eg, organising, organisation

Subheads/crossheads

Cap up initial of first word only, eg, ‘Pharma fights back tiers’.

SmPC vs SPC (Summary of product characteristics)

Always use SmPC, adopted as the correct terminology by EMA working groups. [Note: SPC also stands for Supplementary Protection Certificate (EU) and Special Precautions and Contraindications.]

Split infinitives

Generally acceptable [on the grounds that it adds emphasis where it is important], eg, to thoroughly check the data

sub-Saharan

TTT

targeted

taskforce

(one word)

that or which?

‘that’ defines, ‘which’ gives extra information (often in a clause enclosed by commas): ‘this is the house that Jack built’; but ‘this house, which Jack built, is falling down’;

Tip: note that the sentence remains grammatical without ‘that’, but not without ‘which’

titles

• author’s titles (eg, Dr, Mr, Prof) should not be shown in the Author Box, the Contents Page or the Editorial Team listings

• the titles Professor and Dr should be used every time the person is referred to within an article

• no full stops after Dr, Prof, etc

• l/c designated job titles, eg, vice-president, president (but President Obama; the Prime Minister)

treatment-naïve

(hyphenate)

trialling

trillion

a thousand billion (1 followed by 12 noughts), abbreviate like this: $25tn

UUU

uncharted

not unchartered

up to date

no hyphens if, eg, the records are up to date but: in an up-to-date fashion

upon, use ‘on’

eg, ‘based on’ user testing (l/c)

VVV

very

usually very redundant

veto, vetoes, vetoed, vetoing

vice-chair, vice-chancellor, vice-president

(l/c and hyphenate)

WWW

website

l/c, but cap up ‘on the Web’

website URLs not underlined. If followed by a sentence, use a full stop at end, if they end a paragraph or stand alone no full stop.

wellbeing

(one word)

well-known

hyphenate if descriptive, eg, well-known formula; not if the formula is well known

Western

(cap up) as in Western lifestyle, Western diseases; but not geographical areas, eg, western Europe

which or that?

see that or which

while, not whilst

who or whom?

If in doubt, ask yourself how the clause beginning who/whom would read in the form of a sentence giving he, him, she, her, they or them instead: if the who/whom person turns into he/she/they, then ‘who’ is right; if it becomes him/her/them, then it should be ‘whom’. In this example: ‘Johnson was criticised for praising Cameron, whom he admired’ – ‘whom’ is correct because he admired ‘him’.

But in ‘Johnson praised Cameron, who he thought was right’ – ‘who’ is correct, because it is ‘he’ not ‘him’ who is considered right.

XXX

Xerox

TM; use photocopy

x-ray

(hyphenate)